text: sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingReceipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentPortable chain saws for woodworking (section A8 of annex IV)Machinery for underground working of the following types: (section A12 of annex IV)- machinery on rails: locomotives and brake-vans- hydraulic-powered roof supports- internal combustion engines to be fitted to machinery for underground workingManually-loaded trucks for the collection of household refuse incorporating a compression mechanism (section A13 of annex IV)Vehicles servicing lifts (section A15 of annex IV)Devices for the lifting of persons involving a risk of falling from a vertical height of more than 3 metres (section A16 of annex IV)Roll-over protection structures (ROPS) (section B4 of annex IV)Falling-object protective structures (FOPS) (section B5 of annex IV)AGENCIA PER L'ALTA TECNOLOGIA Via Pian dei Carpini 2850127 FIRENZE Italy715Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.) (section B1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentLogic units which ensure the safety functions of bi-manual controls (section B2 of annex IV)Automatic movable screens to protect the presses referred to in 9, 10 and 11 (section B3 of annex IV)INSTITUTO PER LE MACCHINEMOVIMENTO TERRA E VEICOLIFLUORISTRADAVia Canal Bianco, 28 44044 CASSANA Italy716Roll-over protection structures (ROPS) (section B4 of annex IV) Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentFalling-object protective structures (FOPS) (section B5 of annex IV)NEMKO ALFLAB S.P.A. Via Trento e Trieste 116/118 20046 BIASSONO - MILANO Italy717Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentHand-fed surface planing machines for woodworking (section A2 of annex IV)Thicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentBand-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Combined


text: machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Hand-fed tenoning machines with several tool holders for woodworking (section A6 of annex IV)Hand-fed vertical spindle moulding machines for working with wood and analogous materials (section A7 of annex IV)Portable chain saws for woodworking (section A8 of annex IV)Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s. (section A9 of annex IV)Injection or compression plastics-moulding machines with manual loading or unloading (section A10 of annex IV)Injection or compression rubber-moulding machines with manual loading or unloading (section A11 of annex IV)Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.) (section B1 of annex IV)Logic units which ensure the safety functions of bi-manual controls (section B2 of annex IV)Automatic movable screens to protect the presses referred to in 9, 10 and 11 (section B3 of annex IV)GAMBA WORKING GROUP di Gamba Davide Piazza Savoia 4 10122 Torino Italy718Automatic movable screens to protect the presses referred to in 9, 10 and 11 (section B3 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentRoll-over protection structures (ROPS) (section B4 of annex IV)Falling-object protective structures (FOPS) (section B5 of annex IV)ITEVELESA - INSPECCIÓN TÉCNICA DE VEHÍCULOS LEONESA S.A. C/ Gobelas, 47-49 28023 MADRID Spain719For all products listed in annex IV Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentCESI (CENTRO ELETROTECNICO SPERIMENTALE ITALIANO) GIACINTO MOTTA SPA Via Rubattino, 54 20134 MILANO Italy722Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.) (section B1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentLogic units which ensure the safety functions of bi-manual controls (section B2 of annex IV)Automatic movable screens to protect the presses referred to in 9, 10 and 11 (section B3 of annex IV)NOVICON SAS DI R. CASTELLI & C. Via della Fontana 23804 MONTE MARENZO Italy723Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed- sawing machines with fixed tool

type: contracts

jurisdiction: EU


text: during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingHand-fed surface planing machines for woodworking (section A2 of annex IV)Thicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s. (section A9 of annex IV)Injection or compression plastics-moulding machines with manual loading or unloading (section A10 of annex IV)ABS EUROP LTD ABS House1 Frying Pan AlleyE1 7HR LONDON United Kingdom729Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentHand-fed surface planing machines for woodworking (section A2 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentThicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.) (section B1 of annex IV)Logic units which ensure the safety functions of bi-manual controls (section B2 of annex IV)Automatic movable screens to protect the presses referred to in 9, 10 and 11 (section B3 of annex IV)CERTICONTROL S.A. C/ Manresa 1, 8oA 30004 MURCIA Spain730For all products listed in annex IV Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentFACHAUSSCHUSS "DRUCK UND PAPIERVERARBEITUNG"Prüf und Zertifizierungsstelle im BGPRÜFZERTRheinstraße 6-8 65173 WIESBADEN Germany739Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt


text: of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed- sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingFACHAUSSCHUSS "VERWALTUNG"Prüf- und Zertifizierungsstelle im BGPRÜFZERTDeelbögenkamp 4 22281 HAMBURG Germany740Devices for the lifting of persons involving a risk of falling from a vertical height of more than 3 metres (section A16 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentFACHAUSSCHÜSSE "EISEN UND METAL II UND OBERFLÄCHENBEHANDLUNG"Prüf- und Zertifizierungsstelle im BGPRÜFZERTHans-Böckler-Allee 25 30173 HANNOVER Germany741Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentFACHAUSSCHUSS "LEDER"Prüf- und Zertifizierungsstelle im BGPRÜFZERTLortzingstraße 2 55127 MAINZ Germany742Injection or compression plastics-moulding machines with manual loading or unloading (section A10 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentInjection or compression rubber-moulding machines with manual loading or unloading (section A11 of annex IV)DANMARKS JORDBRUGSFORSKNINGForskningscenter BygholmPostboks 536 8700 HORSENS Denmark802Portable chain saws for woodworking (section A8 of annex IV) Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentRoll-over protection structures (ROPS) (section B4 of annex IV)Fallings-object protective structures (FOPS) (section B5 of annex IV)INGENIERIA Y TECNICAS DE CALIDAD S.L. Polg Aurrera - Manzana 1, n° 63- 1a planta 48510 TRAPAGARAN Spain844For all products listed in annex IV Receipt of technical fileCertification of adequacy for the technical fileAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentISTITUTO SERVIZI EUROPEI TECNOLOGICI SRL Via Ciro Menotti 10 41033 CONCORDIA (MO) Italy865Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed-


text: sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloadingReceipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingHand-fed surface planing machines for woodworking (section A2 of annex IV)Thicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Hand-fed tenoning machines with several tool holders for woodworking (section A6 of annex IV)Hand-fed vertical spindle moulding machines for working with wood and analogous materials (section A7 of annex IV)Portable chain saws for woodworking (section A8 of annex IV)Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s. (section A9 of annex IV)Vehicles servicing lifts (section A15 of annex IV)Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.) (section B1 of annex IV)Logic units which ensure the safety functions of bi-manual controls (section B2 of annex IV)TÜV THÜRINGEN ANLAGENTECHNIK GMBH - ZERTIFIZIERUNGSSTELLE FÜR GERÄTESICHERHEIT Melchendorfer Straße 64 99096 ERFURT Germany867Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed- sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingReceipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentHand-fed surface planing machines for woodworking (section A2 of annex IV)Thicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading


text: and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Vehicles servicing lifts (section A15 of annex IV)Devices for the lifting of persons involving a risk of falling from a vertical height of more than 3 metres (section A16 of annex IV)LAIDLER CERTIFICATION - MR PAUL LAIDLER Belaisis Business Centre - Billingham TS23 4 EA Teesside United Kingdom870Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed- sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingHand-fed surface planing machines for woodworking (section A2 of annex IV)Thicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Hand-fed tenoning machines with several tool holders for woodworking (section A6 of annex IV)Hand-fed vertical spindle moulding machines for working with wood and analogous materials (section A7 of annex IV)Manually-loaded trucks for the collection of household refuse incorporating a compression mechanism (section A13 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentAPAVE NORD-OUEST 51, avenue Architecte Cordonnier BP247 59019 Lille cedex France877Manually-loaded trucks for the collection of household refuse incorporating a compression mechanism (section A13 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentVehicles servicing lifts (section A15 of annex IV)MOTOR INDUSTRY RESEARCH ASSOCIATION (MIRA) Watling Street CV10 0TU Nuneaton United Kingdom888Manually-loaded trucks for the collection of household refuse incorporating a compression mechanism (section A13 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentGuards and detachable transmission shafts with universal joints as described in section 3.4.7. (section A14 of annex IV)Devices for the lifting


text: of persons involving a risk of falling from a vertical height of more than 3 metres (section A16 of annex IV)Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.) (section B1 of annex IV)Logic units which ensure the safety functions of bi-manual controls (section B2 of annex IV)Roll-over protection structures (ROPS) (section B4 of annex IV)Falling-object protective structures (FOPS) (section B5 of annex IV)ITS TESTING & CERTIFICATION GMBH Heilbronner Strasse, 5 70771 LEINFELDEN-ECHTERDINGEN Germany905Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed- sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingPortable chain saws for woodworking (section A8 of annex IV)Vehicles servicing lifts (section A15 of annex IV) Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentDevices for the lifting of persons involving a risk of falling from a vertical height of more than 3 metres (section A16 of annex IV)CCQS (UK) LIMITED Southern House, Guildford Road GU22 7UY WOKING United Kingdom1105Circular saws (single- or multiblade) for working with wood and analogous materials or for working with meat and analogous materials: (section A1 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indent- sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed- sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage- sawing machines with fixed tool during operation, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading- sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloadingHand-fed surface planing machines for woodworking (section A2 of annex IV)Thicknessers for one-side dressing with manual loading and/or unloading for woodworking (section A3 of annex IV)Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentBand-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for


text: working with wood and analogous materials or for working with meat and analogous materials (section A4 of annex IV)Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials (section A5 of annex IV)Hand-fed tenoning machines with several tool holders for woodworking (section A6 of annex IV)Hand-fed vertical spindle moulding machines for working with wood and analogous materials (section A7 of annex IV)Portable chain saws for woodworking (section A8 of annex IV)EUROPEAN INSPECTION AND CERTIFICATION COMPANY SA - EUROCERT SA Tatoiou 73 & Char. Trikoupi 14564 ATHENS Greece1128For all products listed in annex IV Receipt of technical fileCertification of adequacy for the technical fileEC Type-examinationAnnex VI Article 8, 2(c), 1st indentAnnex VI Article 8, 2(c), 2nd indentAnnex VI Article 8, 2(b) and 2c, 3rd indentCHAPTER 2PERSONAL PROTECTIVE EQUIPMENTLIST OF BODIES NOTIFIED UNDER DIRECTIVE 89/686/EEC PERSONAL PROTECTIVE EQUIPMENTName and address of the notified bodiesIdentification numberResponsible for the following productsResponsible for the following procedures/modulesAnnexes/articles of the directivesAFNOR CERTIFICATION SA 11, avenue Francis de Pressensé 93571 SAINT-DENIS LA PLAINE CEDEX France49All PPE referred to in Article 8 (4) System for ensuring EC quality of production by means of monitoringArticle 11BNATIONAL STANDARDS AUTHORITY OF IRELAND (NSAI) Glasnevin 9 DUBLIN Ireland50All personal protective equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ (IMQ S.P.A.) Via Quintiliano, 43 20138 MILANO Italy51All categories of personal protective equipment to protect against electrical risksEC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BINSTITUTO PORTUGUÊS DA QUALIDADE Rua António Gião, 2 2829-513 CAPARICA Portugal64Equipment to protect feet and legs and to prevent skidding EC Type-examinationSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11BISTITUTO DI CERTIFICAZIONE EUROPEO PRODOTTI INDUSTRIALI S.R.L. Via Emilia Parmense, 11 A 29010 PONTENURE (PC) Italy66Hearing protection: EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- earmuffs- earplugsProtection against falls from a height:- descenders- guided rigid anchorage arresters- ropes/cords- energy absorbers- personal protective equipment for positioning on the job and the prevention of falls from a height. Work positioning systems- retractable fall prevention equipment- body harnesses- connectors- fall arrest systemsElectrical hazards:- conductive clothing- gloves and mittens of insulating material- muffs of insulating material- adjustable rods for live working EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BISTITUTO DI RICERCHE E COLLAUDIM. MASINI SRLVia Moscova 11 20017 RHO Italy68Special work helmets with high lateral rigidity EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BIndustrial protective gloves for mechanical usesLeather five-finger working glovesProtective gloves against chemical products and micro-organismsProtective gloves against thermal hazards (heat and fire)Protective industrial gloves against chemical attackLowering devicesStopping devices, guided on a rigid


text: anchoring lineStopping devices, guided on a flexible anchoring lineRopesEnergy absorbersWork positioning systemsRetaining systemsRetractable catching systemsBody harnessesConnectorsAnchoring devicesPositioning harnesses and associated equipmentSpecial non-conductive work helmetsGas and combined filtersDust filtersAX gas and combined filters against organic compounds with low boiling pointSX gas and combined filters against compounds specifically namedEmergency filtersEmergency respirators - filters hoods for protection in the event of fireHeadgear to protect against injuries to the skullIndustrial protective helmetsWork helmetsSpecial non-flammable work helmets EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BUNION TECHNIQUE DE L'AUTOMOBILE, DU MOTOCYCLE ET DU CYCLE Autodrome de Linas-Montlhéry - B.P.212 91311 Montlhéry Cedex France69All personal protective equipment for the following purposes: EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BHead protectionINSTITUT NATIONAL DE RECHERCHE ET DE SÉCURITÉ B.P. 27 54501 Vandoeuvre Cedex France70Protective equipment for eyes and face EC Type-examination Article 10Respiratory protective equipment EC Type-examinationEC quality control system for the final productArticle 10Article 11AHearing protection equipment EC Type-examination Article 10LABORATOIRE NATIONAL D'ESSAIS (LNE) 1, rue Gaston Boissier 75724 PARIS CEDEX 15 France71Fall arrest equipment EC Type-examinationEC quality control system for the final productArticle 10Article 11APersonal protective equipment intended to prevent drowning and buoyancy aidsEC Type-examination Article 10Personal protective equipment intended to protect the hand and arm against knife blowsPersonal protective equipment intended to protect the hand and arm against ionizing radiationEC Type-examinationEC quality control system for the final productArticle 10Article 11AAll PPE referred to in Article 8 (4) System for ensuring EC quality of production by means of monitoringArticle 11BClothing providing protection against knife wounds EC Type-examination Article 10Clothing to protect against ionizing radiation EC Type-examinationEC quality control system for the final productArticle 10Article 11AEye protection equipment against laser beams EC Type-examination Article 10INSTITUT FRANÇAIS DU TEXTILE ET DE L'HABILLEMENT Avenue Guy de Collongue 69134 ÉCULLY CEDEX France72Personal protective equipment for sports or leisure activities: EC Type-examination Article 10- Gum shields- Chest protectors and groin protectors- Masks and visors for face protectionProtective clothing EC Type-examination Article 10Personal protective equipment intended to protect the hand and armINSTITUT DE PROTECTION ET DE SÛRETÉ NUCLÉAIRE (CENTRE TECHNIQUE D'HOMOLOGATION DES ÉQUIPEMENTS NUCLÉAIRES) B.P. 6 92265 Fontenay-Aux-Roses Cedex France73Clothing to protect against ionizing radiation EC Type-examination Article 10Apparatus to protect the respiratory tract with a specific gas filter or with a combined gas and particle filter with or without assisted ventilationPersonal protective equipment intended to protect the hand and arm against ionizing radiationCENTRE EXPÉRIMENTAL DE RECHERCHES ET D'ÉTUDES DU BÂTIMENT ET DES TRAVAUX PUBLICS Domaine de Saint-Paul, B.P. 37 78470 Saint-Rémy-les-Chevreuses France74High visibility clothing EC Type-examination Article 10CENTRE TECHNIQUE DU CUIR ET DE LA MAROQUINERIE Parc Sc. T. Garn. - 4, rue Herm. Frankel 69367 Lyon Cedex 07 France75Personal protective equipment intended to protect the hand and arm EC Type-examinationEC quality control system for the final productArticle 10Article 11AAll equipment to protect feet and legsLABORATOIRE DE RECHERCHE ET DE CONTRÔLE DES CAOUTCHOUCS ET DES


text: PLASTIQUES Rue Auber, 60 94408 Vitry-sur-Seine Cedex France76Personal protective equipment intended to protect the hand and arm against chemical and biological risksEC Type-examination Article 10APAVE PARISIENNE 97-103 boulevard Victor Hugo 93400 SAINT OUEN France77All categories of personal protective equipment to protect against electrical risksEC Type-examinationEC quality control system for the final productArticle 10Article 11AINSTITUT NATIONAL DE LA PLONGÉE PROFESSIONNELLE Entrée 3 - Port de la Pointe Rouge 13008 MARSEILLE France78Personal protective equipment for use in diving or hyperbaric conditionsEC Type-examinationEC quality control system for the final productArticle 10Article 11ALABORATOIRE CENTRAL DES INDUSTRIES ÉLECTRIQUES Avenue du Général Leclerc, 33 92266 FONTENAY-AUX-ROSES France81All categories of personal protective equipment to protect against electrical risksEC Type-examinationEC quality control system for the final productArticle 10Article 11AAPAVE LYONNAISE B.P. 3 69811 TASSIN France82Personal protective equipment to protect against falls from a height. EC Type-examinationEC quality control system for the final productArticle 10Article 11ADÉLÉGATION GÉNÉRALE POUR L'ARMEMENT Centre Aéroporté de Toulouse, BP 3023 31024 Toulouse Cedex France83Personal protective equipment to protect against falls from a height. EC Type-examinationEC quality control system for the final productArticle 10Article 11ABSI 389 Chiswick High Road W4 4AL LONDON United Kingdom86Protective clothing (including lifejackets and buoyancy aids) EC Type-examination Article 10Fall arrest equipmentEquipment mentioned above referred to in Article 8 (4) EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BAll equipment to protect feet and legs EC Type-examination Article 10Head protection equipmentEye protection equipmentRespiratory protective equipmentHearing protection equipmentLLOYD'S REGISTER QUALITY ASSURANCE (LRQA) LTDEUROPEAN DIRECTIVE SERVICESMiddlemarch Office Village - Siskin Driv CV3 4FJ Hiramford - Coventry United Kingdom88Following equipment referred to in Article 8 (4): System for ensuring EC quality of production by means of monitoringArticle 11B- Head protection- Eye and face protection- Respiratory protection- Hand and arm protection- Trunk and abdomen protection- Whole body protectionGERMANISCHER LLOYD AG, HAUPTVERWALTUNG Vorsetzen, 32 20459 HAMBURG Germany98Personal protective equipment for EC Type-examinationEC quality control system for the final productArticle 10Article 11A- underwater use- to prevent drowning- to save people from water- for sailing and surfingASOCIACIÓN ESPAÑOLA DE NORMALIZACIÓN Y CERTIFICACIÓN (AENOR) C/ Génova, 6 E-28004 MADRID Spain99All PPE referred to in Article 8 (4) EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BPHYSIKALISCH-TECHNISCHE BUNDESANSTALT - (PTB) Bundesallee, 100 38116 BRAUNSCHWEIG Germany102Eye protectors EC Type-examination Article 10Eye protectors (referred to in Article 8 (4)) EC quality control system for the final product Article 11AHearing protection equipment EC Type-examination Article 10SGS UNITED KINGDOM LIMITED Worle Park, Weston-Super-Mare BS22 OWA SOMERSET United Kingdom120All personal protective equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BBERUFSGENOSSENSCHAFTLICHES INSTITUT FÜR ARBEITSSICHERHEIT Alte Heerstraße, 111 53754 SANKT AUGUSTIN Germany121Personal protective equipment to protect against falls from a height. EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BRespiratory protection devices - diving suitsHearing protection equipmentFoot and


text: leg protective equipment providing protection from heat, cold and mechanical actionEquipment for protecting all or part of the face from heat, cold and mechanical actionHand and arm protective equipment providing protection from heat, cold, chemical, biological and mechanical actionHead protective equipment providing protection from heat and mechanical actionProtective clothing providing protection from heat, cold, climatic influences, chemical and mechanical action, static electricity, highfrequency electro-magnetic radiation and radioactive contaminationHigh visibility warning clothing EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BTÜV PRODUCT SERVICE GMBH Ridlerstraße, 65 80339 MÜNCHEN Germany123A. Personal protective equipment for winter sports EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- Safety bindings for skis and snowboards with arresting devices- Ski sticks- Protective shoes for winter sports- Personal protective equipment to be used where there is a danger of avalanchesEC Type-examination Article 10B. Personal protective equipment for mountaineering- Protective shoes for climbing- Personal protective equipment for special use in ice- Anchorages and connectors for climbing- Ropes- Straps- Slings- Guy ropes- Harnesses- Rope clamps- Personal protective equipment for bivouackingC. Personal protective equipment for water sports- Wetsuits to protect against cold- Personal protective equipment with solid filling to prevent drowning- Swimming aids- Surf trapezeD. Personal protective equipment for individual parts of the body- ProtectorsE. Protective helmets for sportsF. Sports shoes with a protective function (where not specified in Sections A and B)Clothing to protect against ionizing radiation EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BPersonal protective equipment to protect against falls from a height.Protective gloves providing protection from mechanical (except piercing), chemical and microbial actionLGA - LANDESGEWERBEANSTALT BAYERN Tillystraße, 2 90431 Nürnberg Germany125Personal protective equipment intended to prevent drowning and buoyancy aidsEC Type-examination Article 10DEUTSCHE MONTAN TECHNOLOGIE GMBH Am Technologiepark, 1 45307 ESSEN Germany158Protective suits for spraying works EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BProtective suits for works with chemicalsSafety and rescue harnessesProtective industrial helmetsRespiratory devicesAir-supplied suits, helmets-mask combinationsScuba equipmentRespiratory devices for spraying worksPersonal protective equipment to protect against falls from a height.Head protection equipmentCENTRO NACIONAL DE MEDIOS DE PROTECCIÓNINSTITUTO NACIONAL DE SEGURIDAD E HIGIENEAutopista de San Pablo S/N 41007 SEVILLA Spain159All personal protective equipment for professional use, except equipment to protect against ionizing radiation and to prevent drowningEC Type-examination Article 10Equipment mentioned above referred to in Article 8 (4) EC quality control system for the final product Article 11AINSTITUO ESPAÑOL DEL CALZADO Y CONEXAS, ASOCIACIÓN DE INVESTIGACIÓN Poligono Ind. C. Alto - Apart. Correos 253 03600 Elda (Alicante) Spain160Personal protective equipment for legs and feet, for professional use, providing protection against mechanical impact and physical actionEC Type-examination Article 10ASOCIACIÓN DE INVESTIGACIÓN DE LA INDUSTRIA TEXTIL Plaza Emilio Sala 1 3800 ALCOY Spain161Protective clothing EC Type-examination Article 10Personal protective equipment for protecting the upper extremities


text: from aggressive external agents in generalLABORATORIO DE ENSAYOS E INVESTIGACIONES TEXTILES DEL ACONDICIONAMIENTO TARRASENSE Passeig 22 de Julio 218 - Apt Correos 36 08221 TARRASA Spain162Protective clothing EC Type-examination Article 10Personal protective equipment for protecting the upper extremities from aggressive external agents in generalLABORATORIO OFICIAL JOSÉ MARÍA DE MADARIAGA Calle Alenza, 2 28003 MADRID Spain163Mining sector, in particular personal protective equipment to protect the respiratory tract from dangerous substances, as well as antistatic personal protective equipment for legs and feet in explosive atmosphereEC Type-examination Article 10IDIADA AUTOMOTIVE TECHNOLOGY S.A. L'Albornar 43710 SANTA OLIVA Spain164Cycling helmets (for sport or professional use) EC Type-examination Article 10Helmets for downhill skiers (for sport or professional use)Helmets for small children (for sport or domestic use)General protective clothing for motorcyclists (for sport or professional use)PFI - PRÜF- UND FORSCHUNGSINSTITUT PIRMASENS E.V. Hans-Sachs Straße 2 66955 PIRMASENS Germany193Foot and leg protectors: EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BSafety shoes, protective shoes and working shoesINSPEC INTERNATIONAL LTD Upper Wingbury Courtyard - Wingrave HP22 4LW AYLESBURY United Kingdom194Filtering respiratory devices (excluding any intended to provide protection against radiotoxic gases)EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BRespiratory protection devices providing full insulation from the atmosphere (excluding those for use in diving)Protective clothing for chainsaw operators EC Type-examination Article 10Fall arrest equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BEquipment mentioned above referred to in Article 8 (4) EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BProtective clothing EC Type-examinationEC quality control system for the final productArticle 10Article 11ASystem for ensuring EC quality of production by means of monitoringArticle 11BAll equipment to protect feet and legsHead protection equipmentEye protection equipmentRespiratory protective equipment EC Type-examination Article 10Hearing protection equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BLifejacketsPersonal buoyancy aidsDIN CERTCO GESELLSCHAFT FÜR KONFORMITÄTSBEWERTUNG MBH Burggrafenstraße 6 10787 BERLIN Germany196Eye protection equipment with or without face protection EC Type-examination Article 10Eye protection equipment with or without face protection, referred to in Article 8 (4)EC quality control system for the final product Article 11ATÜV RHEINLAND PRODUCT SAFETY GMBH Am Grauen Stein 51105 Köln Germany197PPE providing protection from falling EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BPersonal protective equipment intended to prevent drowning and buoyancy aidsAll equipment to protect feet and legsPersonal protective equipment intended to protect the hand and armHead protection equipmentProtective helmetsProtective clothingEye and face protectionFORCE INSTITUT, FORCE-DANTEST CERT Park Alle 345 2605 Brøndby Denmark200Equipment mentioned above referred to in Article 8 (4) EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle


text: 11AArticle 11BFoot protection equipment EC Type-examination Article 10Protective helmetsFall arrest equipmentRespiratory protective equipmentProtective clothing and buoyancy aidsDEUTSCHE GESELLSCHAFT ZUR ZERTIFIZIERUNG VON MANAGEMENTSYSTEMEN MBH - QUALITÄTS- UND UMWELTGUTACHTER August-Schanz Straße, 21 60433 FRANKFURT AM-MAIN Germany297Following personal protective equipment referred to in Article 8 (4): System for ensuring EC quality of production by means of monitoringArticle 11B- Respiratory devices- Equipment against electrical hazardsFall arrest equipment- Abseiling equipment- Safety and rescue harnesses- Mountaineering equipmentProtective clothing- Protective suits for work with chemicals- Flame-proof clothing- Low temperature clothing- Suits for the application of plant protection products- Heat-protective clothing- Protective gloves and shoes against chemical and thermal hazardsEquipment mentioned above referred to in Article 8 (4)FACHAUSSCHUSS PERSÖNLICHE SCHUTZAUSRÜSTUNGEN PRÜF- UND ZERTIFIZIERUNGSSTELLE IM BG-PRÜFZERT Klinkerweg 4 40699 ERKRATH Germany299Abseiling equipment EC Type-examination Article 10Safety and rescue harnessesGlovesIndustrial helmetsBoots and shoesProtective equipment to prevent drowningMountaineering equipmentComponents for safety and rescue harnessesEye protection devices, protective glassesEquipment mentioned above referred to in Article 8 (4) EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BProtective clothing EC Type-examination Article 10Respiratory protective equipmentExcept where affording protection against: EC Type-examination Article 10- ionizing radiation- spurious arc lighting- laser beamsAGENZIA NAZIONALE CERTIFICAZIONE COMPONENTI E PRODOTTI SRL Via Bronzino, 3 20133 MILANO Italy302Lowering devices EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BStopping devices, guided on a rigid anchoring lineStopping devices, guided on a flexible anchoring lineRopesEnergy absorbersWork positioning systemsRetractable catching systemsBody harnessesGoggles for professional and industrial use (radiation protection)Filters for welding and ancillary techniquesUltraviolet filtersInfra-red filtersFilters for welding with a transmission factor in the switchable visible and filters with double transmission factor in the visibleHigh-visibility signalling clothingProtective clothing where there is a risk of entanglement in moving partsProtective gloves for users of chainsawsProtective clothing for the use of chainsaws (protection of feet); welding spats, leg protectionProtective filters and goggles against laser raysProtective goggles for laser adjustmentConnectorsCatching systemsRetaining systemsAnchoring devicesPositioning harnesses and accessoriesProtective clothing against external irradiationEC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BProtective clothing against splashes of liquid metalProtective clothing against liquid chemicals or aerosolsProtective clothing against chemicalsMERCHANDISE TESTING LABORATORIES (UK) LTD Oakhurst House - 57 Ashbourne Road DE22 3FS DERBY United Kingdom319Clothing, general protection: hand, arm, body EC Type-examinationEC quality control system for the final productArticle 10Article 11AGloves: abrasion, puncture, tear protection EC Type-examination Article 10Equipment mentioned above referred to in Article 8 (4) EC quality control system for the final product Article 11AHigh visibility protection EC Type-examinationEC quality control system for the final productArticle 10Article 11ANATIONAL ENGINEERING LABORATORY East Kilbride G75 0QU GLASGOW United Kingdom320Fall arrest: industrial safety belts, self-locking anchorages, lines, safety belts, harnesses, safety lanyardsEC Type-examinationEC quality control system for the final productArticle 10Article 11ASATRA TECHNOLOGY CENTRE Satra House - Rockingham Road NN16 9JH KETTERING United Kingdom321All types of safety, protective and occupational footwear and leg protectors.EC Type-examinationEC quality control system for


text: the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BClothing for high visibility protection.Protective clothing for chainsaw operatorsPersonal protective equipment for sports and leisureMotor cycle clothing.Protective clothing (including that against radioactive contamination, and against liquid and gaseous chemicals, including aerosols and solid particles).Fall arrest equipmentDry suits / diving suits.Deck safety harness and safety line for use on recreational craftHelmets for equestrian use EC Type-examination Article 10Helmets for alpine skiersHelmets for airborne sportsProtective helmets for pedal cyclists and for users of skateboards and skatesClimber's safety helmets EC Type-examination Article 10Head protectors for ice hockey players (but not including full face protectors, eye protectors and teeth protectors)Gloves and clothing to provide protection against: EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- chemical hazards- heat, flame and cold- mechanical and cutting risksIndustrial scalp protectors EC Type-examination Article 10Industrial safety helmetsIndustrial bump capsProtection skull caps for jockeysProtective hats for horse and ponyridersHelmets for canoeing and white water sportsHelmets for firefightersASSOCIATION FRANÇAISE POUR L'ASSURANCE QUALITÉ (AFAQ) Avenue Aristide Briand, 116 - B.P.40 92224 Bagneux Cedex France333All personal protective equipment System for ensuring EC quality of production by means of monitoringArticle 11BASSOCIATION POUR LA PROMOTION DE L'ASSURANCE QUALITÉ DANS LA FILIÈRE DU TEXTILE ET DE L'HABILLEMENT (ASQUAL) Rue des Reculettes, 14 75013 PARIS France334All personal protective equipment System for ensuring EC quality of production by means of monitoringArticle 11BProtective clothing EC quality control system for the final product Article 11APersonal protective equipment intended to protect the hand and armTNO CERTIFICATION B.V. Laan Westenenk 501, Postbus 541 7300 AM APELDOORN Netherlands336Protective clothing EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BEquipment to protect feet and legs and to prevent skiddingPersonal protective equipment intended to protect the hand and armHearing protection equipment EC Type-examination Article 10BRITISH TEXTILE TECHNOLOGY GROUP (BTTG) Wira House, West Park Ring Road LS16 6QL LEEDS United Kingdom338Protective clothing against chemical hazards EC Type-examinationEC quality control system for the final productArticle 10Article 11AProtective clothing protecting against foul weatherProtective gloves against chemicals and micro-organismsProtective clothing: high visibility warningLimited use: protective clothing with spray-tight connections between different parts of the clothing (type 4)Protective clothing:Limited use: protective clothing with liquid-tight connections between different parts of the clothing (type 3)BRITISH TEXTILE TECHNOLOGY GROUP - FIRE TECHNOLOGY SERVICES Unit 4B Stag Industrial Estate - Broadhe WA14 5DW Alchincham United Kingdom339Protective clothing, gloves protecting against heat and flame EC Type-examinationEC quality control system for the final productArticle 10Article 11AFACHAUSSCHUSS "ELEKTROTECHNIK" PRÜF-UND ZERTIFIZIERUNGSSTELLE IM BG-PRÜFZERT Gustav-Heinemann-Ufer 130 50968 Köln Germany340Eye protection devices and equipment: EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- Protective eye glasses for electricians- Laser-protection eye glassesProtective devices for the eyes and eyesight:- Protective helmets for electricians- Protective screens and visors for electriciansElectrically insulated protective clothing:- Sleeves- Suits- Gloves- Means of protecting


text: the body against live components- Shoes- Boots- OvershoesPersonal alarms:- Contact monitoring devices- Personal alarm signalling devicesINTERTEK TESTING SERVICES (LEICESTER) LTD Centre Court - Meridian Business Park LE3 2WR LEICESTER United Kingdom362Safety, protective and occupational footwear EC Type-examination Article 10Gloves and clothing to provide protection against:- chemical hazards- mechanical action- heat and flameDEUTSCHE PRÜFSTELLE FÜR LAND- UND FORSTTECHNIK Weissensteinstraße 70/72 34114 KASSEL Germany363Gloves and suits for the application of plant protection products EC Type-examination Article 10Cut protection for power saw operatorsEquipment mentioned above referred to in Article 8 (4) EC quality control system for the final product Article 11AELOT - HELLENIC ORGANIZATION FOR STANDARDIZATION Acharnon Street 313 11145 ATHENS Greece365Protective helmets EC Type-examination Article 10Safety shoes for professional useGloves giving mechanical protectionVDE - VERBAND DER ELEKTROTECHNIK ELEKTRONIK INFORMATIONSTECHNIK E.V. - VDE PRÜF-UND ZERTIFIZIERUNGSSTELLE Merianstraße, 28 63069 OFFENBACH (AM MAIN) Germany366Personal protective equipment against electrical risks and for works under dangerous tensionEC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BPersonal protective equipment used as insulation in high-tension work EC Type-examinationEC quality control system for the final productArticle 10Article 11ALABORATORI GENERAL D'ASSAIGS I INVESTIGACIONS (LGAI) Campus UAB, Apto Correos 18 8193 BELLATERRA Spain370Personal protective equipment intended to prevent drowning and buoyancy aidsEC Type-examination Article 10ORGANISMO DI CERTIFICAZIONE EUROPEA SRL Via Ancona, 21 00198 ROMA Italy397Personal protective equipment to protect against falls from a height.EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BEye protection equipmentProtective glovesEquipment providing total/partial face protection, including sports use EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BGloves protecting against chemical products and microorganismsHearing protection:- earmuffs- earplugsProtection against falls from a height:- descenders- guided rigid anchorage arresters- body harnesses- connectors- fall arrest systemsElectrical hazards:- conductive clothing- gloves and mittens of insulating material- muffs of insulating material- adjustable rods for live workingSP - SWEDISH NATIONAL TESTING AND RESEARCH INSTITUTE LTD Box 857 501 15 BORAS Sweden402Equipment for protection against falls from height and head protection EC Type-examination Article 10High visibility warning clothingProtective clothing - protection against heat and chemicalsEquipment for protection against falls from height and head protection, referred to in Article 8 (4)Protective clothing - protection against heat and chemicalsEC quality control system for the final product Article 11AAll types of helmets System for ensuring EC quality of production by means of monitoringArticle 11BPersonal protective equipment against falls from heightProtective clothing - protection against heat and chemicalsRespiratory protection devices - diving suitsProtective clothing EC Type-examination Article 10Head protection equipmentFINNISH INSTITUTE OF OCCUPATIONAL HEALTH (DEPARTMENT OF PHYSICS) Laajaniityntie 1 FIN - 01620 VANTAA Finland403Respiratory protective devices EC Type-examination Article 10Protective clothing for users of hand held chainsawsSafety, protective and occupational footwearBuoyancy aids, lifejackets, armbands and lifesaving suitsPersonal protective equipment to protect against falls from a heightEquipment to protect feet and legs and to prevent skidding- Masks and visors for face protectionProtective clothingEye


text: protection equipmentHearing protection equipmentProtective helmetsProtective glovesEquipment mentioned above referred to in Article 8 (4) EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BSVENSK MASKINPROVNING AB - SMP Fyrisborgsgatan 3 754 50 UPPSALA Sweden404Clothing protection against cutting EC Type-examination Article 10Boots for users of handheld chainsawsRespiratory protective equipment EC Type-examinationEC quality control system for the final productArticle 10Article 11AHearing protection equipment EC Type-examination Article 10TÜV-ÖSTERREICH Krugerstrasse 16 1015 Wien Austria408All categories of equipment to prevent falls from a height, including accessories (for work and leisure, especially for mountaineering)EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BClothing providing protection against mechanical impactAll equipment to protect feet and legsSFS-SERTIFIOINTI OY Maistraatinportti 2 PL 116 00241 HELSINKI Finland416Industrial helmets EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BFlotation equipmentEar protectorsProtective equipment against cutting for forestry workersProtective footwear, safety footwear and working footwear EC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 11AArticle 11BCONSORZIO ITALCERT Viale Sarca, 336 20126 MILANO Italy426Work positioning systems EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BRetaining systemsRetractable catching systemsBody harnessesConnectorsPositioning harnesses and associated equipmentNipples for face piecesGas and combined filtersDust filters (excluding those in the coal mining industry)AX gas and combined filtersAX gas and combined filters against organic compounds with low boiling pointSX gas and combined filters against compounds specifically namedComplete nosepieceComplete masksComplete masks for special usesSelf-contained open-circuit compressed air breathing apparatusFresh air hose breathing apparatusAirline respiratorsHalf and quarter masksValves for gas cylinders - nipplesDust filter electrorespirators with helmets or hoodsDust filter electrorespirators with full, half or quarter masksDust filtering facepiecesSelf-contained open-circuit compressed air breathing apparatus for underwater useFresh air electrorespirators with hoodAirline respirators with hoodAirline respirators for use in sanding operationsStopping devices, guided on a rigid anchoring lineStopping devices, guided on a flexible anchoring lineRopesCONSORZIO ITALCERT Energy absorbers EC Type-examinationMATERIALPRÜFUNGSAMT NORDRHEIN-WESTFALEN (MPA NRW)Marsbruchstraße 186 D - 44287 DORTMUND Germany432Eye protection devices, except against laser beams and welding EC Type-examinationEC quality control system for the final productArticle 10Article 11AA.N.C.I. - SERVIZI S.R.L. - SEZIONE CIMAC (CENTRO ITALIANO MATERIALI APPLICAZIONE CALZATURIERA) Corso Bradolini, 19 27029 VIGEVANO Italy465Personal protective equipment of lower limb EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BIndustrial protective gloves for mechanical usesLeather five-finger working glovesProtective gloves for users of chainsawsGloves giving mechanical protectionGloves protecting against cold ( >-50 °C)Gloves protecting against cold (<= -50 °C)Protective industrial gloves against chemical attackGloves protecting against chemical products and microorganismsGloves protecting against thermal hazardsPersonal protective equipment against electrical risks and dangerous voltages or that used as insulation in high-tension work:- gloves and mittens of insulating materialREGISTRO ITALIANO NAVALE Via Corsica 12 16128 GENOVA Italy474Complete nosepieces EC Type-examinationEC quality control system


text: for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BFull masksFull masks for special useSelf-contained closed-circuit oxygen breathing apparatus EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BSelf-contained closed-circuit oxygen breathing apparatus for special useRescue jackets and coatsSelf-contained open-circuit compressed air breathing apparatusSelf-contained open-circuit compressed air breathing apparatus for underwater useCERMET Via Aldo Moro, 22 40068 S. LAZZARO DI SAVENA Italy476All personal protective equipment System for ensuring EC quality of production by means of monitoringArticle 11BRAPRA TECHNOLOGY LIMITED Shawbury - Shrewsbury SY4 4NR Shropshire United Kingdom478Protective gloves EC Type-examinationEC quality control system for the final productArticle 10Article 11ASafety and protective footwearDU PONT (UK) LIMITED - KEVLAR PLANT - GLOVES & FABRIC TESTING LABORATORY Maydown Works - PO Box 15 BT47 1TU LONDONDERRY United Kingdom479Protective gloves EC Type-examination Article 10INSTITUT SCIENTIFIQUE DES SERVICES PUBLICS - SIÈGE DE COLFONTAINE Rue Grande, 60 7340 COLFONTAINE France492Protective breathing equipment, excluding diving equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BWETENSCHAPPELIJK EN TECHNISCH CENTRUM VAN DE BELGISCHETEXTIELNIJVERHEID - DIVISIE GENT Technologiepark - Zwijnaarde, 7 9052 ZWIJNAARDE Belgium493Clothing and gloves for protection against dangerous substances (chemical products) and infectious agentsEC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BProtective clothing and gloves for use in potentially explosive atmospheresProtective clothing which may be caught up during useClothing capable of signalling the user's presence visuallyClothing and gloves for protection against heat and fireClothing and gloves for protecting against cold and normal bad weatherClothing and gloves for protection against physical injury EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BINDUSTRIAL ENGINEERING CONSULTANTS SRL Via Botticelli, 151 10154 Torino Italy495Hearing protection equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BCONSORZIO DNV - MODULO UNO Via Paracelso 20, 20041 AGRATE BRIANZA Italy496Hearing protection: EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- earmuffs- earplugsProtection against falls from a height:- descenders- guided rigid anchorage arrestersCENTRO SVILUPPO SETTORE IMPIEGO SPA (CSI) Via Lombardia, 20 20021 Bollate Italy497Helmets for skiers EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BWork helmetsHelmets for cyclistsSpecial non-flammable work helmetsSpecial work helmets with high lateral rigiditySpecial non-conductive work helmetsSafety helmets for motor racingHelmets for mountaineeringHelmets for bobsleighingFireman's helmetsHeadgear to protect against injuries to the skullHelmets for skateboard and roller skatesRiding hatsSkullcaps for jockeysHead protectionProtective clothing for all or part of the body- gloves EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- footwear for professional use- textile


text: productsRICOTEST Via Einaudi 6/8 37010 CASTELNUOVO DEL GARDA Italy498Protective footwear EC Type-examinationEC quality control system for the final productArticle 10Article 11AProtective clothing for motorcyclists (excluding helmets and visors)Industrial protective glovesC.R.I.T.T. SPORTS ET LOISIRS Rue Albert-Einstein, Zone du Sanital 86100 CHATELLERAULT France501Personal protective equipment for sports or leisure activities: EC Type-examination Article 10- Masks and visors for face protection- protective helmets for sports use- Gum shields- Chest protectors and groin protectors- life-buoys and life-jackets- life-jackets designed for recreational sailingALLGEMEINE UNFALLVERSICHERUNGSANSTALT SICHERHEITSTECHNISCHE PRÜFSTELLE Adalbert Stifter Straße, 65 1200 Wien Austria511Safety shoes, protective shoes and working shoes EC Type-examination Article 10Personal protective equipment to prevent falls from a height, including accessories (for work and leisure, especially equipment for mountaineering)Equipment mentioned above referred to in Article 8 (4) EC quality control system for the final product Article 11AHearing protection equipment EC Type-examination Article 10Protective helmetsISOQAR LIMITED Metropolitan House - City Park Business M16 9HQ MANCHESTER United Kingdom513Protective gloves - leather and synthetic coated System for ensuring EC quality of production by means of monitoringArticle 11BProtective clothing - disposable suits made from paper and plastic materialsRespiratory protection devices - diving suits- Masks and visors for face protection System for ensuring EC quality of production by means of monitoringArticle 11BFLEETWOOD TESTING LABORATORTY - BLACKPOOL & THE FYLDE COLLEGEFleetwood Nautical Campus - Broadwater FY7 8JY Fleetwood United Kingdom514Life jackets and buoyancy aids EC Type-examination Article 10Protective clothing (survival suits) - constant wear suits and abandonment suitsFACHAUSSCHUSS TIEFBAU PRÜF- UND ZERTIFIZIERUNGSSTELLE IM BG-PRÜFZERT Landsberger Straße 309 80687 MÜNCHEN Germany515Scuba equipment EC Type-examinationEC quality control system for the final productArticle 10Article 11ASÄCHSISCHES TEXTILFORSCHUNGSINSTITUT E.V. Annaberger Straße, 240 9125 CHEMNITZ Germany516Following personal protective equipment: EC Type-examinationEC quality control system for the final productArticle 10Article 11A- Weather protection clothing- Low temperature clothing- Dust-proof clothing- Warning clothing- Heat-protective clothing- Flame-proof clothing- Protective clothing for the fire service- Chemical-proof clothing- Protective gloves against chemical, mechanical, electrical and thermal hazards, with the exception of protective gloves reinforced with metal ringsProtective clothing against mechanical hazards EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BElectrically insulated protective clothingEquipment mentioned above referred to in Article 8 (4) System for ensuring EC quality of production by means of monitoringArticle 11BAntistatic protective clothing EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BCERTOTTICA - SOCIETÀ CONSORTILE A.R.L. PER LA CERTIFICAZIONE DEI PRODOTTI OTTICI Via Fortogna, 1 32010 LONGARONE Italy530Protective goggles for laser adjustment EC Type-examinationEC quality control system for the final productArticle 10Article 11AProtective filters and goggles against laser beamsInfra-red filtersUltraviolet filtersFilters for welding and ancillary techniquesGlasses for occupational uses (glare, radiation, high-speed impact, for drivers)Protective visorsFilters for weldingÖSTERREICHISCHES TEXTILFORSCHUNGSINSTITUT Spengergasse 20 1050 Wien Austria534Protective clothing against: EC Type-examination Article 10- mechanical action- weather conditions- heat, whether or not involving infrared radiation- chemical action- contamination with dangerous substancesProtective gloves against thermal risksSame equipment where category III (Article 8 (4)) EC quality control system for


text: the final product Article 11ASOCIEDAD ESTATAL DE SALVAMENTO Y SEGURIDAD MARITIMACENTRO DE SEGURIDAD MARITIMA INTEGRAL 33393 Veranes Spain540Personal protective equipment intended to prevent drowning and buoyancy aidsEC Type-examination Article 10FORSCHUNGSINSTITUT HOHENSTEINPROF. DR. JÜRGEN MECHEELS GMBH & CO.KG Schloß Hohenstein 74357 Bönnigheim Germany555Following items of personal protective equipment under Article 8 (2) (4) of the Directive:EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- Weather protection clothing- Low temperature clothing- Warning clothing- Heat protective clothing- Flame-proof clothing EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11B- Protective clothing for the fire service- Chemical-proof clothing- Protective clothing against mechanical hazardsDRA BRIDGEWATER Bridgewater - Puriton TA7 8AD SOMERSET United Kingdom557Air filter systems for use with respiratory protective equipment EC Type-examinationEC quality control system for the final productArticle 10Article 11ANATIONAL LEATHER CENTER Thisseos 7a - Kallithea 176 76 ATHENS Greece619High visibility clothing EC Type-examinationEC quality control system for the final productArticle 10Article 11AProtective glovesSafety shoes for professional useGloves giving mechanical protectionProtective clothing for all or part of the body- gloves- footwear for professional use- textile productsASSOCIAZIONE CERTITEX Viale Sarca, 223 20123 MILANO Italy621Protective clothing for all or part of the body System for ensuring EC quality of production by means of monitoringArticle 11B- gloves- footwear for professional use- textile productsSOCIETÀ ITALIANA CERTIFICAZIONE INDUSTRIALE S.r.l. Via Fiorini, 5 42100 REGGIO EMILIA Italy623All products covered by the Directive System for ensuring EC quality of production by means of monitoringArticle 11BCENTRO TESSILE COTONIERO E ABBIGLIAMENTO SPA Piazza S. Anna, 2 21052 BUSTO ARSIZIO Italy624High-visibility clothing EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BProtective clothing for use where there is a risk of being caught up in moving partsProtective clothing, gloves and accessories against cold ( > -50 °C) EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BProtective clothing, gloves and accessories against cold (<= -50 °C)Protective clothing for firemenProtective clothing, gloves and accessories for welding, etc.Personal protective equipment intended to protect the hand and arm against chemical and biological risksPersonal protective equipment for sports or leisure activities:- protective clothing- glovesAntistatic protective clothingProtective clothing, gloves and accessories for workers exposed to heatGloves protecting against mechanical hazardsAFAQ-ASCERT INTERNATIONAL B.P.83 - 116 avenue Aristide Briand 92225 Bagneux Cedex France639All personal protective equipment System for ensuring EC quality of production by means of monitoringArticle 11BLABORATORIO PROVE TECNOLOGICHE SNC Via G. Urbino, 62/A 26013 Crema Italy721Fall arrest equipment EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BLABORATORIO PREVENZIONE INCENDI SRL Via della Quercia, 11 59100 PRATO Italy987Clothing protecting against heat and flames EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BProtective clothing for


text: firemen (except protective clothing, gloves and accessories for welding, etc.)CENTRO TECNOLÓGICO DAS INDÚSTRIAS TÊXTIL E DO VESTUÁRIO DE PORTUGAL - CITEVE Rua Fernando Mesquita, 2785 (Q. da Maia) 4760-034 VILA NOVA DE FAMALICÃO Portugal1074Protective clothing EC Type-examinationEC quality control system for the final productSystem for ensuring EC quality of production by means of monitoringArticle 10Article 11AArticle 11BPersonal protective equipment intended to protect the hand and armCHAPTER 4MEDICAL DEVICESLIST OF BODIES NOTIFIED UNDER DIRECTIVE 98/79/EC IN VITRO DIAGNOSTIC MEDICAL DEVICESName and address of the notified bodiesIdentification numberResponsible for the following productsResponsible for the following procedures/modulesAnnexes/articles of the directivesRWTÜV ANLAGENTECHNIK GMBH Langemarkstrasse, 20 45138 ESSEN Germany44The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugarFull quality assurance systemProduction quality assuranceAnnex IVAnnex VIIImmunochemestry pregnancy testEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIILLOYD'S REGISTER QUALITY ASSURANCE (LRQA) LTDEUROPEAN DIRECTIVE SERVICESMiddlemarch Office Village - Siskin Driv CV3 4FJ Hiramford - Coventry United Kingdom88Self test devices for urinalysis, endocrinology, general chemistry, general immunology and haematologyEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIIReagents and reagent products, including related calibrators and control materials, for controlling the following blood groups: ABO system, Rhesus (C, c, D, E, e), anti-KellFull quality assurance systemProduction quality assuranceAnnex IVAnnex VIIReagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, and CReagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-KiddReagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodiesReagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosisReagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydiaReagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, BThe following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugarReagents and reagent products, including related calibrators and control materials, for determining the following hereditary disease: phenylketonuriaReagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSAProduction quality assurance Annex VIITÜV PRODUCT SERVICE GMBH Ridlerstraße, 65 80339 MÜNCHEN Germany123Devices for self-testingEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIIProducts referred in Annex II, list AFull quality assurance systemEC Type-examinationProduction quality assuranceAnnex IVAnnex VAnnex VIIProducts referred in Annex II, list BFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIIDEKRA CERTIFICATION SERVICES (DCS) GMBH Handwerkstraße 15 70565 STUTTGART Germany124Devices for self-testingEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIILGA - LANDESGEWERBEANSTALT BAYERN Tillystraße, 2 90431 Nürnberg Germany125Devices for self-testingEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIIThe following device for self-diagnosis, including its related calibrators


text: and control materials: device for the measurement of blood sugarFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIITÜV RHEINLAND PRODUCT SAFETY GMBH Am Grauen Stein 51105 Köln Germany197Devices for self-testingEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIIProducts referred in Annex II, list AFull quality assurance systemEC Type-examinationProduction quality assuranceAnnex IVAnnex VAnnex VIIProducts referred in Annex II, list BFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIITNO CERTIFICATION B.V. Laan Westenenk 501, Postbus 541 7300 AM APELDOORN Netherlands336In vitro diagnostic medical devicesEC declaration of conformityFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IIIAnnex IVAnnex VAnnex VIAnnex VIIKEMA QUALITY B.V. Utrechtseweg 310 ( Postbus 9035 ) 6800 ET ARNHEM Netherlands344All devices referred in Annex IIFull quality assurance systemProduction quality assuranceAnnex IVAnnex VIIAll devices for self-testingEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIITÜV-ÖSTERREICH Krugerstrasse 16 1015 Wien Austria408Devices for self-testingEC declaration of conformityFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IIIAnnex IVAnnex VAnnex VIAnnex VIIProducts referred in Annex II, list AFull quality assurance system Annex IVEC Type-examinationProduction quality assuranceAnnex VAnnex VIIProducts referred in Annex II, list BFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIIG-MED GROUPEMENT POUR L'ÉVALUATION DES DISPOSITIFS MÉDICAUX 33, avenue du Général Leclerc BP n° 8 92260 FONTENAY-AUX-ROSES France459In vitro diagnostic medical devicesEC declaration of conformityFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IIIAnnex IVAnnex VAnnex VIAnnex VIIAMTAC CERTIFICATION SERVICES LTD Norman Road - Broadheath WA14 4EP ALTRINCHAM United Kingdom473All self-test devices which have existing notified body (NB) certification via their original manufacturerEC declaration of conformityFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IIIAnnex IVAnnex VAnnex VIAnnex VIIAll Annex II list A devices which have existing notified body (NB) certification via their original manufacturerAll Annex II list B devices which have existing notified body (NB) certification via their original manufacturerFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIIMDC MEDICAL DEVICE CERTIFICATION GMBH Heilbronner Strasse 43 70191 STUTTGART Germany483Devices for self-testingEC declaration of conformityFull quality assurance systemProduction quality assuranceAnnex IIIAnnex IVAnnex VIIReagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosisFull quality assurance systemProduction quality assuranceAnnex IVAnnex VIIReagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydiaReagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSAThe following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugarEUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH Wittichstrasse, 2 64295 DARMSTADT Germany535Devices for self-testingFull quality assurance systemProduction quality assuranceAnnex IVAnnex VIIThe following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugarVTT INDUSTRIAL SYSTEMS (VTT TUOTTEET JA TUOTANTO) P.O. Box 13001 33101 Tampere Finland537Reagents and reagent products, including related calibrators and control materials, for controlling the following blood groups: ABO system, Rhesus (C, c, D, E, e), anti-KellReagents and reagent


text: products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and DReagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-KiddReagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodiesReagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosisReagents and reagent products, including related calibrators and control materials, for determining the following hereditary disease: phenylketonuriaReagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydiaReagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, BReagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSAThe following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugarFull quality assurance system Annex IVSelf diagnosis devices for determining pregnancy and ovulationEC declaration of conformityFull quality assurance systemAnnex IIIAnnex IVDANSK GODKENDELSE AF MEDICINSK UDSTYR (DGM) Kollegievej, 6 2920 CHARLOTTENLUND Denmark543Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), and hepatitis B, and CFull quality assurance systemEC Type-examinationProduction quality assuranceAnnex IVAnnex VAnnex VIIReagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosisFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIIReagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirusReagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSAUL INTERNATIONAL (UK) LTD Wonersh House Building C, Old Portsm. R. GU3 1LR GUILDFORD United Kingdom843All self-test devices which have existing notified body (NB) certification via their original manufacturerEC declaration of conformity Annex IIISelf diagnosis devices for determining pregnancy and ovulationEC declaration of conformity Annex IIISelf diagnosis devices for determining cholesterolFull quality assurance system Annex IVDevices for the determination of toxoplasmosis, rubella, cytomegalovirus and chlamydiaFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIIAnti-duffy, anti-kidd, irregular anti-erythrocytic antibodies (list B) ABO system, rhesus (C, c, D, E, e) anti-Kell (list A) HIV 1 and 2, HTLV I and II, and hepatitis B, C and D (list A)All Annex II and all self-test devices which have existing notified body(NB) certification via their original manufacturerFull quality assurance systemEC Type-examinationProduction quality assuranceAnnex IVAnnex VAnnex VIIDevices for the determination of PSAThe following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugarFull quality assurance system Annex IVAll Annex II list B and all self-test devices which have existing notified body (NB) certification via their original manufacturerEC verification Annex VILABORATÓRIO DE ENSAIOS


text: E METROLOGIA DA SAÚDE - LEMES Av. Padre Cruz, Complexo Inst. Ricardo J 1699 Lisboa Codex Portugal932In vitro diagnostic medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceAnnex IVAnnex VAnnex VIAnnex VIILIST OF BODIES NOTIFIED UNDER DIRECTIVE 90/385/EEC ACTIVE IMPLANTABLE MEDICAL DEVICESName and address of the notified bodiesIdentification numberResponsible for the following productsResponsible for the following procedures/modulesAnnexes/articles of the directivesNATIONAL STANDARDS AUTHORITY OF IRELAND (NSAI) Glasnevin 9 DUBLIN Ireland50All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC declaration of conformity to type (assurance of production quality)Annex 2Annex 5BSI 389 Chiswick High Road W4 4AL LONDON United Kingdom86All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 5TÜV PRODUCT SERVICE GMBH Ridlerstraße, 65 80339 MÜNCHEN Germany123All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5LGA - LANDESGEWERBEANSTALT BAYERN Tillystraße, 2 90431 Nürnberg Germany125All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5TÜV RHEINLAND PRODUCT SAFETY GMBH Am Grauen Stein 51105 Köln Germany197All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5DEUTSCHE GESELLSCHAFT ZUR ZERTIFIZIERUNG VON MANAGEMENTSYSTEMEN MBH - QUALITÄTS- UND UMWELTGUTACHTER August-Schanz Straße, 21 60433 FRANKFURT-AM-MAIN Germany297Active implantable medical devices (pacemakers, biostimulators, nerve stimulators, muscle stimulators, bladder stimulators, sphincter stimulators, diaphragm stimulator and ear stimulators)EC declaration of conformity (complete quality assurance system)EC declaration of conformity to type (assurance of production quality)Annex 2Annex 5TÜV ZERTIFIZIERUNGSGEMEINSCHAFT e. V.TÜV CERTReuterstraße, 161 53113 BONN Germany298All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC declaration of conformity to type (assurance of production quality)Annex 2Annex 5BUREAU VERITAS QUALITY INTERNATIONAL (BVQI) 2nd Floor, Tower Bridge Road, 224-226 SE1 2TX LONDON United Kingdom301All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC declaration of conformity to type (assurance of production quality)Annex 2Annex 5DIRECCIÓN GENERAL DE FARMACIA Y PRODUCTOS SANITARIOS - MINISTERIO DE SANIDAD Y CONSUMO PO del Prado, 18-20 28014 MADRID Spain318All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5KEMA QUALITY B.V. Utrechtseweg 310 ( Postbus 9035 ) 6800 ET ARNHEM Netherlands344All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 5CENTRUM VOOR MEDISCHE TECHNOLOGIE VAN HET INSTITUUT VOOR VEROUDERINGS- EN VAATZIEKTEN ONDERZOEK TNO Zernikedreef, 9 2333 CK LEIDEN Netherlands345All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5ISTITUTO SUPERIORE DI SANITA Viale Regina Elena, 299 00161 ROMA Italy373All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type


text: (assurance of production quality)Annex 2Annex 3Annex 4Annex 5TÜV-ÖSTERREICH Krugerstrasse 16 1015 Wien Austria408All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5G-MED GROUPEMENT POUR L'ÉVALUATION DES DISPOSITIFS MÉDICAUX 33, avenue du Général Leclerc BP no 8 92260 FONTENAY-AUX-ROSES France459All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Vorsetzen 32 20459 HAMBURG Germany482Active implantable medicinal devices and their accessoriesEC declaration of conformity (complete quality assurance system)EC declaration of conformity to type (assurance of production quality)Annex 2Annex 5PRÜFANSTALT FÜR MEDIZINISCHE GERÄTETECHNISCHE UNIVERSITÄT GRAZ Inffeldgasse, 18 8010 GRAZ Austria636Active implantable medicinal devices and their accessoriesEC Type-examinationEC verificationAnnex 3Annex 4LABORATÓRIO DE ENSAIOS E METROLOGIA DA SAÚDE - LEMES Av. Padre Cruz, Complexo Inst. Ricardo J 1699 Lisboa Codex Portugal932All active implantable medical devicesEC declaration of conformity (complete quality assurance system)EC Type-examinationEC verificationEC declaration of conformity to type (assurance of production quality)Annex 2Annex 3Annex 4Annex 5LIST OF BODIES NOTIFIED UNDER DIRECTIVE 93/42/EEC MEDICAL DEVICESName and address of the notified bodiesIdentification numberResponsible for the following productsResponsible for the following procedures/modulesAnnexes/articles of the directivesAPRAGAZ A.S.B.L. Chaussée de Vilvorde 156 1120 BRUXELLES Belgium29Class IIa non-invasive devices for gas storage, distribution or administrationFull quality assurance systemEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IVAnnex VAnnex VIClass IIb active devices for administering gas and/or extracting medicines/substancesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VITÜV NORD CERT GMBH & CO. KG Am TÜV 1 30519 HANNOVER Germany32Active medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VITÜV ANLAGENTECHNIK GMBH UNTERNEHMENSGRUPPE TÜVRHEINLAND/BERLIN-BRANDENBURGAm Grauen Stein D-51105 Köln Germany35Active medical devices:EC Type-examinationEC verificationAnnex IIIAnnex IV- equipment for infusions- anaesthesia devices, respirators and oxygen therapy equipment- vital-parameter monitoring and plotting devices- surgical equipment and ancillary surgical equipment- stimulation devices- ophtalmological devices- dental equipment- prostheses and rehabilitation devices- disinfection and sterilization equipment- radiotherapy equipment with non-ionizing radiation- medical supply units- patient storage and transport equipment- imaging equipment:- with ionizing radiation- with non-ionizing radiationRWTÜV ANLAGENTECHNIK GMBH Langemarkstrasse, 20 45138 ESSEN Germany44Non-active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- orthopaedic implants- soft tissue implants- function implantsFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- disposable medical devices- anaesthetic, orthopaedic and rehabilitation products- non-energized medical instrumentation- reusable non-active medical instruments- bandages and dressings- suture material and clamps- dental equipment and instruments- dental materials- dental implantsActive medical devices:- devices to ascertain vital functions- equipment for extracorporeal circuits, infusions and haemophoresis- anaesthesia devices, incubators, respirators and oxygen therapy equipment- surgical equipment and ancillary surgical equipment- stimulation devices- ophtalmological devices- dental equipment- prostheses and rehabilitation devices- disinfection and sterilization equipment- radiotherapy devices:- with ionizing radiation and with non-ionizing radiation- with non-ionizing radiation- imaging equipment:- with ionizing radiation- with non-ionizing radiationNATIONAL STANDARDS AUTHORITY OF IRELAND


text: (NSAI) Glasnevin 9 DUBLIN Ireland50All medical devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ (IMQ S.P.A.) Via Quintiliano, 43 20138 MILANO Italy51Eye examination equipmentFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIEquipment for electrosurgery and accessoriesAnaesthetics equipment, incubators, ventilators, oxygen therapy equipment and accessoriesEquipment for extracorporeal circulation, infusion, transfusion, haemophoresis and accessoriesEquipment for dialysis and accessoriesEquipment for checking and recording vital functions and accessoriesCardiac and muscular stimulation equipment and accessoriesDental equipment and accessoriesOphtalmological equipment and accessoriesDisinfection and sterilization equipmentEquipment for aerosol therapy and accessoriesClinical imaging equipment using ionizing radiation, non-ionizing radiation and ultrasoundTreatment equipment using ionizing radiation, non-ionizing radiation and ultrasoundDisposable syringesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIUrethral catheters, catheters for heart surgery and for the central cirulatory systemBags for parenteral and enteral nutrition and accessoriesContact lensesSolutions for contact lensesAuditory prosthesesISTITUTO DI RICERCHE E COLLAUDI M. MASINI SRL Via Moscova 11 20017 RHO Italy68Equipment for aerosol therapy, humidification and nebulisationFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIEquipment for anaesthesia, assisted ventilation and support of vital functions- surgical equipment and ancillary surgical equipmentEquipment for electrosurgeryEquipment for peritoneal dialysis and hemodialysis- Equipment for endoscopyEquipment for infusion, transfusion, extracorporeal circulation, plasmapheresis and blood collectionFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIEquipment for the production, visualisation and processing of images using non-ionising radiation or ultrasoundEquipment for measuring and/or monitoring and/or recording and/or analysing physiological parameters and vital functionsDental instruments (non sterile) equipmentEquipment for rehabilitationEquipment for nerve, heart or muscle stimulation or electrotherapyEquipment for treatment using non-ionising radiation or ultrasoundIncubators and equipment for neonatal pathologyNon-active devices for anaesthesia and assisted ventilationNon-active devices for surgery and endoscopyNon-active devices for measuring physiological parametersBSI 389 Chiswick High Road W4 4AL LONDON United Kingdom86All medical devicesEC verificationProduct quality assuranceAnnex IVAnnex VIAll medical devices including medical devices incorporating human blood derivativesFull quality assurance systemEC Type-examinationProduction quality assuranceAnnex IIAnnex IIIAnnex VLLOYD'S REGISTER QUALITY ASSURANCE (LRQA) LTDEUROPEAN DIRECTIVE SERVICESMiddlemarch Office Village - Siskin Drive CV3 4FJ Hiramford - Coventry United Kingdom88All medical devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIBAYERISCHES LANDESAMT FÜR MASS UND GEWICHT Franz-Schrank Straße, 9 80638 MÜNCHEN Germany104Active medical devices: Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- measuring devices to determine body temperature- tonometers- non-invasive sphygmomanometers- audiometers- therapy dosimeters- diagnostic dosimetersLANDESAMT FÜR MESS- UND EICHWESEN DES LANDES BRANDENBURG Stahnsdorfer Damm, 81 14532 KLEINMACHNOW Germany106Electrical thermometers for clinical useNon-invasive sphygmomanometersEC verification Annex IVLANDESAMT FÜR MESS- UND EICHWESEN THÜRINGEN Unterpörlitzer Straße, 2 98693 ILMENAU Germany118Active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- measuring devices to determine body temperature- tonometers- non-invasive sphygmomanometers- flow meters- devices to monitor and determine vital signs- imaging equipment:- with non-ionizing radiation- radiotherapy equipment with non-ionizing radiation- stimulation devicesMedical weighing instrumentsNon-active medical devices used for measurement:- clinical mercury-in-glass, maximum reading thermometers- medical syringes- tonometers- non-invasive sphygmomanometers-