text: 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 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


text: 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 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

type: contracts

jurisdiction: EU


text: 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 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


text: 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 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


text: 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 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,


text: 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 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


text: 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 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


text: 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 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


text: 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 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


text: 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 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


text: 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 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


text: 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 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


text: 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 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


text: 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 (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


text: 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 (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


text: 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- devices to ascertain vital functions- flow metersSGS UNITED KINGDOM LIMITED Worle Park, Weston-Super-Mare BS22 OWA SOMERSET United Kingdom120All medical devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIInfusion / syringe pumpsEC Type-examination Annex IIIGeneral electro / mechanical equipment- stimulation devicesEC verification Annex IV- defibrillators EC Type-examination Annex III- condoms and contraceptive pessaries EC Type-examinationEC verificationAnnex IIIAnnex IVEquipment and accessories for dialysisEC Type-examination Annex III- ElectrocardiographsBlood pressure measurement devicesElectrical thermometers for clinical useEC verification Annex IVTÜV PRODUCT SERVICE GMBH Ridlerstraße, 65 80339 MÜNCHEN Germany123Non-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 implants- 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- disinfectants and antiseptics- radiotherapy devices:- with ionizing radiation and with non-ionizing radiation- with non-ionizing radiation- imaging equipment:- with ionizing radiation- with non-ionizing radiationFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIDEKRA CERTIFICATION SERVICES (DCS) GMBH Handwerkstraße 15 70565 STUTTGART Germany124Non-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 implants- 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 radiationFull quality assurance systemEC Type-examinationEC verificationAnnex IIAnnex IIIAnnex IVLGA - LANDESGEWERBEANSTALT BAYERN Tillystraße, 2 90431 Nürnberg Germany125Non-active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- orthopaedic implants- soft tissue implants- funtion implants- disposable medical devices- anaethestic, orhtopaedic and rehabilitation products- non-energized medical instrumentation- reusable non-active medical instruments- bandages and dressings- suture material and clamps- dental equipment and instruments- 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 radiationTÜV RHEINLAND


text: PRODUCT SAFETY GMBH Am Grauen Stein 51105 Köln Germany197Active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- devices to ascertain vital functions- stimulation equipment- anaesthesia devices, incubators, respirators and oxygen therapy equipment- equipment for extracorporeal circuits, infusions and haemophoresis- ophtalmological devices- surgical equipment and ancillary surgical equipment- dental equipment- prostheses and rehabilitation devices- disinfection and sterilization equipment- radiotherapy devices:- with non-ionizing radiation- with ionizing radiation and with non-ionizing radiation- imaging equipment:- with ionizing radiation- with non-ionizing radiationNon-active medical devices:- orthopaedic implants- soft tissue implants- function implants- suture material and clamps- anaesthetic, orthopaedic and rehabilitation devices- non-energized medical instrumentation- reusable non-active medical instruments- bandages and dressings- dental equipment and instruments- dental materials- dental implantsFull quality assurance systemEC Type-examinationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex VAnnex VIDEUTSCHE GESELLSCHAFT ZUR ZERTIFIZIERUNG VON MANAGEMENTSYSTEMEN MBH - QUALITÄTS- UND UMWELTGUTACHTER August-Schanz Straße, 21 60433 FRANKFURT-AM-MAIN Germany297Non-active medical devices:Full quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- soft tissue implants- function implants- disposable medical productsFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- anaesthetic, orthopaedic and rehabilitation devices- orthopaedic implants- non-energized medical instrumentation- bandages and dressings- reusable non-active medical instruments- 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 excluding heart-lung machines- 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 equipment with non-ionizing radiation- imaging equipment:- with ionizing radiation- with non-ionizing radiationTÜV ZERTIFIZIERUNGSGEMEINSCHAFT e. V.TÜV CERTReuterstraße, 161 53113 BONN Germany298Active medical devices:Full quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- devices to ascertain vital functions- equipment for extracorporeal circuits, infusions and haemoforesis- anaesthesia devices, incubators, respirators and oxygen therapy equipmentFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- 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 radiationDIRECCIÓN GENERAL DE FARMACIA Y PRODUCTOS SANITARIOS - MINISTERIO DE SANIDAD Y CONSUMO PO del Prado, 18-20 28014 MADRID Spain318All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VITNO CERTIFICATION B.V. Laan Westenenk 501, Postbus 541 7300 AM APELDOORN Netherlands336All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIKEMA QUALITY B.V. Utrechtseweg 310 ( Postbus 9035 ) 6800 ET ARNHEM Netherlands344All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIITS TESTING AND CERTIFICATION LTD ITS House, Cleeve Road KT22 7SB Leatherhead United Kingdom359Active medical devices but excluding:EC Type-examinationEC verificationAnnex IIIAnnex IV- blood gas analysers (in vivo)- anaesthesia machines- lung ventilators- respiratory therapy equipment- breathing systems attachments and componentsEC Type-examinationEC verificationAnnex IIIAnnex IV- extracoporeal blood treatment equipment- electrosurgical equipment- medical laser equipment- defibrillators- radiotherapy equipment-


text: radionuclide and magnetic resonance imagingVDE - VERBAND DER ELEKTROTECHNIK ELEKTRONIK INFORMATIONSTECHNIK E. V. - VDE PRÜF- UND ZERTIFIZIERUNGSSTELLE Merianstraße, 28 63069 OFFENBACH (AM MAIN) Germany366Active medical devices, except:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- disinfection and sterilization equipmentISTITUTO SUPERIORE DI SANITA Viale Regina Elena, 299 00161 ROMA Italy373All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIISTITUTO DI RICERCHE, PROVE E ANALISI SRL Via Artigiani, 63 25040 BIENNO Italy398Single-use productsFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIEquipment for electrosurgeryFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIApparatus and accessories for muscle stimulationEquipment and accessories for infusion, perfusion and transfusionEquipment and accessories for diagnosis and treatment using ultrasoundEquipment and accessories for dialysisEquipment and accessories for diagnostic imaging, using ionising and non-ionising radiationEquipment and accessories for treatment using ionising and non-ionising radiation- patient-monitoring equipment and equipment for recording vital functions- disinfection and sterilization equipmentFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VISP - SWEDISH NATIONAL TESTING AND RESEARCH INSTITUTE LTD Box 857 501 15 BORÅS Sweden402Non active devices specifically intended for recording of X-ray diagnostic images (Annex IX, 4.4. Rule 16)Full quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIEquipment for anaesthesia and intensive careBone anchored implants for dental and craniofacial reconstructionsDiagnostic X-ray equipmentSurgical instruments for single useElectromedical diagnostic equipmentDental devicesAll Class I sterile devicesClass I devices with a measuring functionProduction quality assuranceProduct quality assuranceAnnex VAnnex VITÜV-ÖSTERREICH Krugerstrasse 16 1015 Wien Austria408Active medical devices (including their accessories)Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VINon-active medicinal devices (including accessories)Bone nails, screws and plates (including accessories)- Disposable products- For preserving/conducting blood, other body fluids and tissue, liquids and gases- For contraception- Dressings- Dental products excluding dental materials- Cleaning, disinfecting and sterilizing devices- Products for endoscopy and endoscopic surgery- Non-implantable products for orthopaedics and rehabilitationAll Class I sterile devices Production quality assurance Annex VSEMKO AB Torshamnsgatan, 43 164 22 KISTA Sweden413Active therapeutic devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIActive devices intended for diagnosisDevices for the administration to or removal from the patient's body of medicines, body fluids or other substancesFull quality assurance systemAnnex IIRe-usable devicesDisposablesWound dressingsPassive implantsDental devicesFunctional implantsDevices with a measuring functionSterile devicesElectrical devices intended to administer and/or remove medicines orproducts, body liquids or other substances to or from the bodyEC Type-examinationEC verificationAnnex IIIAnnex IVElectrical therapeutic devicesElectrical devices intended for diagnosisClass I devices with a measuring functionEC verificationAnnex IVCONSORZIO ITALCERT Viale Sarca, 336 20126 MILANO Italy426Devices in sterile packsProduction quality assuranceProduct quality assuranceAnnex VAnnex VIMeasuring devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VISingle-use products- dental materials- dental equipment- ultrasound equipment- electrocardiographs and electroencephalographs- contact lensesNon-invasive devices in contact with damaged skinOrthopaedic implantsDevices for contact lens treatmentDevices for the sterilisation of medical devicesInvasive devices for natural orificesInvasive devices for surgical useProbes and catheters for urology, gastroenterology, respiratory tracts, surgical aspiration


text: and oxygen therapyDevices for the administration to or removal from the patient's body of medicines, body fluids or other substancesContraceptivesFull quality assurance systemAnnex IIBlood bagsProducts and accessories for surgical use, such as suture needles, syringes, surgical glovesApparatus and accessories for muscle stimulationMATERIALPRÜFUNGSAMT NORDRHEIN-WESTFALEN (MPA NRW) Marsbruchstraße 186 D - 44287 DORTMUND Germany432Active medical devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- radiotherapy equipment with non-ionizing radiation- hearing aids and audiometers- ultrasound equipment- imaging equipment:- with ionizing radiation- with non-ionizing radiationG-MED GROUPEMENT POUR L'ÉVALUATION DES DISPOSITIFS MÉDICAUX 33, avenue du Général Leclerc BP n° 8 92260 FONTENAY-AUX-ROSES France459All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VINEMKO ASAMTAC CERTIFICATION SERVICES LTDNorman Road - Broadheath WA14 4EP ALTRINCHAM United Kingdom473All medical devices except equipment emitting ionising radiationFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VICERMET Via Aldo Moro, 22 40068 S. LAZZARO DI SAVENA Italy476Electromedical apparatus for physiotherapy and rehabilitationFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIElectromedical apparatus for cardiologyElectromedical apparatus for anaesthesia and cardiac surgeryElectromedical apparatus for dentistry and stomatologyFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIElectromedical apparatus for nephrology and dialysisElectromedical apparatus for pediatrics and neonatal careProsthesesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIDental prosthesesOrthopaedic prosthesesInfusion and withdrawal needlesCannulas, probes and tubesCatheters and accessoriesTubular devices of synthetic material for administration and withdrawalsFilters for blood or solutions; other filtersSyringesCircuits and accessories for anaesthesia and resuscitationEquipment and accessories for dialysisProducts for dental treatmentBIOLAB SPA - CENTRO DI ANALISI E RICERCHE BIOLOGICHE Via Bruno Buozzi, 2 20090 VIMODROME Italy477Non-resorbable surgical implantsEC Type-examinationEC verificationAnnex IIIAnnex IVDevices for infusion, transfusion, injection, withdrawal, extracorporeal circuits- ophtalmological devices- disinfectants and antisepticsContact lenses maintenance productsNon-resorbable suture materials and clampsSingle-use productsDressingsDevices, materials and apparatus for dental treatmentSurgical instrumentsGloves for medical useContraceptivesDevices for anaesthesia and ventilationEC Type-examinationEC verificationAnnex IIIAnnex IVCatheters, drains and probesRe-usable devicesDevices for parenteral and enteral nutritionAll Class I sterile devicesProduction quality assuranceProduct quality assuranceAnnex VAnnex VIECM ZERTIFIZIERUNGSGESELLSCHAFT FÜR MEDIZINPRODUKTE IN EUROPA MBH Eifelstraße, 1C 52068 AACHEN Germany481Non-active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- disposable medical products:- infusion / transfusion sets- catheters / catheter sets- drainage devices- tubing for extracorporeal circulation- OP products- bandages and dressings- soft tissue implantsFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- disinfection means- orthopaedic implants- contact lenses- contact lens care productsMEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSHAFT FÜR DIE MEDIZIN GMBH Vorsetzen 32 20459 HAMBURG Germany482Non-active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- orthopaedic implants- soft tissue implants- disposable medical products- function implants- non-energized medical instrumentation- anaesthetic, orthopaedic and rehabilitation productsFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- reusable non-active medical instruments- bandages and dressings- suture material and clamps- dental equipment and instruments- dental materials- dental implantsActive medical devices:- patient storage and transport equipment- imaging equipment using non-ionizing radiation, with the exception


text: of MR- X-ray equipment apart from CT and angiography- surgical equipment and accessories, including lithotriptors; Hf, Laser and ultra-sound surgery; endoscopes- vital-parameter monitoring and plotting devices- breathing apparatus and oxygen-therapy equipment including hyperbaric therapy chambers- equipment for extracorporeal circuits, infusions and haemophoresis- inhalation anaesthesizing equipment- stimulation devices- ophtalmological devices- dental equipment- prostheses and rehabilitation devices- disinfection and sterilization equipment- radiotherapy equipment with non-ionizing radiation- medical supply unitsMDC MEDICAL DEVICE CERTIFICATION GMBH Heilbronner Strasse 43 70191 STUTTGART Germany483Non-active medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIActive medical devices:- devices to ascertain vital functions- infusion devices- ventilators and oxygen therapy apparatus, except for devices for hyperbaric therapy- surgical devices and aids, except for lithotripsy devicesEC Type-examinationProduction quality assuranceProduct quality assuranceAnnex IIIAnnex VAnnex VI- imaging equipment:- with ionizing radiation- with non-ionizing radiation- stimulators, except external pacemakers and defibrillators- radiotherapy devices:- with ionizing radiation and with non-ionizing radiation- ophtalmological devices- dental equipment- rehabilitation devices and active prostheses- patient storage and transport equipment- medical supply unitsSLG PRÜF- UND ZERTIFIZIERUNGS GMBH Burgstädedter Strasse 20 09232 Hartmannsdorf Germany494- Narcosis devices, incubators, ventilators and oxygen therapy apparatus, except for devices for hyperbaric therapyFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- surgical equipment and ancillary surgical equipment- ophtalmological devices- dental equipment- disinfection and sterilization equipment- radiotherapy equipment with non-ionizing radiation- medical supply units- patient storage and transport equipmentEquipment for measuring and/or monitoring and/or recording and/or analysing physiological parameters and vital functionsEquipment for rehabilitationAuditory prosthesesSoftware for operating medical devices- Devices for imaging processes with non-ionizing radiation, except for nuclear spin tomography devices- Radiation therapy devices using non-ionizing radiation, except for laser therapy devices- stimulators- dental treatment devices- rehabilitation devices and active prostheses- patient storage and transport equipment- devices for medical careFull quality assurance systemEC Type-examinationEC verificationProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VISOCIETE NATIONALE DE CERTIFICATION ET D'HOMOLOGATION S.À.R.L. (SNCH) 11, Route de Sandweiler 5230 SANDWEILER Luxembourg499All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIINSTITUTO NACIONAL DA FARMACIA E DO MEDICAMENTO Parque da Saúde de Lisboa - Av. do Brasil 1700 LISBOA Portugal503Non-active medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VISIRA CERTIFICATION SERVICE SIRA TEST & CERTIFICATION LIMITED South Hill BR7 5EH Chislehurst - Kent United Kingdom518All active medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIEUROCAT - INSTITUTE FOR CERTIFICATION AND TESTING GMBH Wittichstrasse, 2 64295 DARMSTADT Germany535Non-active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- software for the operation of medical products- medical supply units- patient storage and transport equipment, excluding incubators- surgical aidsActive medical devices:- stimulation devices- disinfection and sterilization equipment- prostheses and rehabilitation devices- surgical equipment and ancillary surgical equipment- equipment for extracorporeal circuits, infusions and haemophoresis- ophtalmological devices- dental equipment- Narcosis devices, incubators, ventilators and oxygen therapy apparatus, except for devices for hyperbaric therapy- devices to monitor and determine vital


text: signs- devices for extracorporeal circulation, infusions and haemopheresis- radiotherapy devices:- with ionizing radiation and with non-ionizing radiation- with non-ionizing radiation- imaging equipment: Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- with ionizing radiation- with non-ionizing radiationVTT INDUSTRIAL SYSTEMS (VTT TUOTTEET JA TUOTANTO) P.O. Box 13001 33101 Tampere Finland537Active medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VINon-active class I devices placed on the market in a sterile stateNon-active class I devices with a measuring functionEC verificationProduction quality assuranceProduct quality assuranceAnnex IVAnnex VAnnex VINon-active class IIa and IIb devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIZDH-ZERT [RECHTSNACHFOLGER IS DIE MDC MEDICAL DEVICE CERTIFICATION GMBH, KENN-NR 0483, STUTTGART] Heilbronner Strasse, 43 70191 STUTTGART Germany538Non-active medical devicesFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- orthopaedic implants- reusable non-active medical instruments- dental equipment and instruments- disposable productsActive medical devices:- high frequency surgery equipment- dental equipment- hearing aids and audiometers- devices to monitor and determine vital signs- ventilators and oxygen therapy apparatus, except for devices for hyperbaric therapy- surgical devices and aids, except for lithotripsy devices- electrical stimulation and acupuncture devices, hydro electric bath- short waves and devices for treatment using heat- rehabilitation devices and active prostheses- patient storage and transport equipmentDANSK GODKENDELSE AF MEDICINSK UDSTYR (DGM) Kollegievej, 6 2920 CHARLOTTENLUND Denmark543Non-active medical devices:Full quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VI- infusion devices- dental materials- bandages and dressings- dental implants- disinfection means- surgical articles- contact lenses- contact lens fluids- sutures and adhesives- condoms and contraceptive pessaries- intrauterine contraceptives- drains, probes and suction devices- surgical implants (non-orthopaedic implants and bone cement)Active medical devices:- radiotherapy equipment- radiotherapy planning software- stimulation equipment- heart-lung machines- neonatal equipment- dental devices- hearing aids and audiometers- electrocardiographs and electroencephalographs- medical equipment sterilizers- defibrillators- equipment for measuring blood and anaesthesic gas- surgical lasers- ultrasound equipment- patient-monitoring equipment and equipment for recording vital functions- electrosurgical equipment- single use products for heart-lung machines- cardiovascular implants- suction equipmentISTITUTO DI CERTIFICAZIONE DELLA QUALITÀ PER L'INDUSTRIA CHIMICA Via G. Giardino, 4 20123 MILANO Italy546Medical and measuring equipment with independent power supply or non-poweredFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIDental products and materials and accessories, including powered accessoriesOphtalmic products, e.g. spectacles and intraocular lensesProducts and accessories for surgical useProducts for endoscopy and laparoscopySensitive materials for medical useProducts for extracorporeal circulation and accessories, including active accessoriesCatheters and non-disposable accessoriesContraceptive productsArtificial skin, etc.Products for disinfection of medical equipment and for the treatment of contact lensesBendages, dressings, plasters, etc.Materials for suturesDisposable productsProducts for anaesthesia, reanimation and respirationOrthopaedic and rehabilitation products and materials and accessories, including powered accessoriesMEDICAL PRODUCTS AGENCY(LÄKEMEDELSVERKET)Box 26 751 03 UPPSALA Sweden562Non-active medical devicesFull quality assurance systemProduction quality assuranceAnnex IIAnnex VNATIONAL QUALITY ASSURANCE LTD Gainsborough House - Houghton Hall Park W5 5XZ Houghton Regis, Dunstable United Kingdom577Devices for the administration to or removal from the patient's body of medicines, body fluids or other substancesFull quality assurance systemProduction quality assuranceProduct


text: quality assuranceAnnex IIAnnex VAnnex VI- ultrasound equipmentElectromedical equipmentAnaesthetic and life support equipmentFull quality assurance systemAnnex IIDrainage and suction devices (non-powered)Surgical dressings (class IIa)Measuring and monitoring equipmentOperating theatre equipmentDiagnostic X-ray equipmentAnaesthetic and respiratory equipmentProduction quality assuranceProduct quality assuranceAnnex VAnnex VIBlood contact devicesFunctions relating to sterile / measuring Class I medical devicesBERLIN-CERT-PRÜF- UND ZERTIFIZIERSTELLE FÜR MEDIZINPRODUKTE GMBH AN DER TECHNISCHEN UNIVERSITÄT BERLIN Dovestrasse, 6 10587 BERLIN Germany633Active medical devices: EC Type-examinationEC verificationAnnex IIIAnnex IV- Narcosis devices, incubators, ventilators and oxygen therapy apparatus, except for devices for hyperbaric therapy- Surgical devices and aids, except for lithotripsy, ultrasound and laser surgery devices- anaesthetic, orthopaedic and rehabilitation devices- prostheses and rehabilitation devices- dental equipment- non-energized medical instrumentation- reusable non-active medical instruments- radiotherapy equipment with non-ionizing radiation- medical supply units- patient storage and transport equipment- dental equipment and instruments- devices to monitor and determine vital signs- Radiation therapy devices using non-ionizing radiation, except for laser therapy devices- Devices for imaging processes with non-ionizing radiation, except for nuclear spin tomography devices- devices for extracorporal circulation, infusions and haemopheresis- dental treatment devicesNon-active medical devices:- dental materials- dental implants- condoms made from natural latex- stimulators- patient storage and transport equipment- devices for medical care- Dressings- Cleaning, disinfecting and sterilizing devicesOrthopaedic implantsSoft tissue implantsFunctional implantsSingle-use medical devicesPRÜFANSTALT FÜR MEDIZINISCHE GERÄTETECHNISCHE UNIVERSITÄT GRAZ Inffeldgasse, 18 8010 GRAZ Austria636Active medical devices and their accessoriesEC Type-examinationEC verificationAnnex IIIAnnex IVRESEARCH CENTER FOR BIOMATERIALS S.A."EKEVYL S.A."Smyrnis 15 165 62 GLYFADA Greece653All medical devicesProduction quality assuranceProduct quality assuranceAnnex VAnnex VIAll medical devicesFull quality assurance system Annex IIImplantable and non-implantable orthopaedic materials and devicesOther implantable devicesEC Type-examination Annex IIIArtificial limbs and related components for disabledBandages, surgical dressings, medical grade cotton and other relevant productsDental devicesDisinfectants and antisepticsContact lenses and solutions for contact lensesAbsorbable and non-absorbable surgical sutures- disinfectants and antisepticsAbsorbable and non-absorbable surgical suturesSterile and non-sterile single use productsContraceptivesContact lenses maintenance productsAbsorbable and non-absorbable surgical suturesSterile and non-sterile single use productsContraceptivesOnly devices mentioned in § BEC verificationAnnex IVINTERNATIONAL CERT ZERTIFIZIERUNG GMBH Straubinger Straße 2 94333 GEISELHÖRING Germany712- dental equipment and instrumentsFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VI- dental materials- dental implants- reusable non-active medical instrumentsPRÜF- UND FORSCHUNGSINSTITUT FÜR DIE SCHUHHERSTELLUNG E.V. Hans-Sachs-Straße 2 66955 PIRMASENS Germany713Non-active, non-sterile medical devices for orthopaedic treatement and the rehabilitation of the foot and leg (Category IIa)Full quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VIUL INTERNATIONAL (UK) LTD Wonersh House Building C, Old Portsm. R. GU3 1LR GUILDFORD United Kingdom843Active medical devices and their accessoriesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex IVAnnex VAnnex VIDisinfectants and surgical instrumentsFull quality assurance systemProduction quality assuranceProduct quality assuranceAnnex IIAnnex VAnnex VISterile single use medical devices excluding Class III devices, ophthalmic devices, (class IIa and above) and implantsWound dressings (Class IIa and IIb)EC Type-examinationEC verificationAnnex IIIAnnex IVGloves for medical useUrethral cathetersEC verification Annex IVLABORATÓRIO DE ENSAIOS E METROLOGIA DA SAÚDE - LEMES Av. Padre Cruz, Complexo Inst. Ricardo J 1699 Lisboa Codex Portugal932All medical devicesFull quality assurance systemEC Type-examinationEC verificationProduction quality assuranceProduct quality assuranceAnnex IIAnnex IIIAnnex