Source: http://realab.ua/en/products/swabs
Timestamp: 2020-07-07 00:10:28
Document Index: 793047496

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 1']

Swabs - РЕАЛАБ - дистриб’ютор провідних світових виробників: Феноменекс (витратні матеріали для хроматографії та пробопідготовки), Хоневелл Ресьорч Кемікалс (високочисті реагенти), Дельталаб (вироби з лабораторного та медичного пластику, загальнолабораторне приладдя)
HYDRANAL KFT chemicals
Swabs for microbiological sampling
Swabs are used for biological sampling. Specially used for processing samples which, after being coloured, will be analysed by microscopy. Also suitable for isolations in culture medium. Another important use is its capacity to spread dishes by dissemination techniques (for example for susceptibility testing by Kirby-Bauer or by E-test).
Swabs class IIa
The swabs for the collection and transport of microbiological samples are considered invasive surgical-type product and with a use, in compliance with the essential requirements of the “Directive 93/42/EEC. Medical devices”. According to the classification rules contained in this Directive, the swabs are part of Class IIa. The Agencia Española del Medicamento y Productos Santarios (AEMPS – ON 0318) is the institution who certifies these swabs.
Quality standards – Requirements fulfilled by swabs
1. UNE-EN ISO 556-1 Sanitary products sterilisation. Requirements to be designed as “STERILE”. Part 1: sterilised sanitary products requirements.
2. UNE-EN ISO 868-2 Packaging materials for medical devices sterilized in its final phase. Part 2: sterilization wrap. Requirements and test methods.
3. UNE-EN ISO 11737-1 Sterilization of medical devices. Microbiological methods. Part 1: determination of a population of microorganisms.
4. UNE-EN ISO 11737-2 Sterilization of medical devices. Microbiological methods. Part 2: sterility tests conducted to validate a sterilization process.
5. UNE-EN ISO 11135-1 Sterilization of medical devices. Ethylene oxide. Part 1: requirements for development, validation and control of the routine of a sterilization process of medical devices.
6. UNE-EN ISO 11137-1 Sterilization of health care products. Radiation. Part 1: requirements for the development, validation, and control of the routine of a sterilization process of PS.
7. UNE-EN ISO 11137-2 Sterilization of health care products. Radiation. Part 2: setting the sterilization dose.
8. UNE-EN ISO 15223-1 Sanitary products. Symbols to use on labels, labelling and information to be supplied. Part 1: general requirements.
9. UNE-EN ISO 14971 Sanitary products. Application of risk on management.
10. UNE-EN ISO 13485 Sanitary products. Systems of quality management. Requirements for regulatory purposes.
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SWAB 200X2.5 WOOD+COTTON / 80X100 / MDD
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SWAB WOOD+COTTON / 100X100 / MDD
SWAB PP+COTTON / 40X100 / MDD
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SWAB ALUM+COTTON / 10X100 / MDD
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SWAB (WOOD STICK ONLY) / 1000
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SWAB I/W PEEL/1 WOOD+COTTON / 2X1000 / MDD
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WOOD+COTTON SWAB FLOW / 2X1000 / MDD
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SWAB I/W PEEL/1 PS+COTTON / 2X1000 / MDD
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SWAB I/W PEEL/1 PS+VISCOSE / 2X1000 / MDD
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PS+VISCOSE SWAB FLOW / 2X1000 / MDD
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SWAB I/W PEEL ALUM+COTTON / 2X1000 / MDD
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SWAB B/2 PEEL/2 WOOD+COTTON / 1000 / MDD
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SWAB B/2 PS+COTTON PEEL/2 / 1000 / MDD
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SWAB IN TUBE WOOD+COTTON / 4X500 / MDD
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SWAB IN TUBE WOOD+VISCOSE / 4X500 / MDD
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SWAB IN TUBE PS+COTTON / 4X500 / MDD
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SWAB IN TUBE PS+VISCOSE / 4X500 / MDD
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SWAB IN TUBE ALUM+COTTON / 4X500 / MDD
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SWAB IN TUBE ALUM+VISCOSE / 4X500 / MDD
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SWAB 13X165MM PS W/POLYESTER / 4X500 / MDD
Products filter Swabs
Dry swabs (23) Enrichment media Selenite Broth (1) Flocked swabs with Amies media (4) Flocked swabs with Cary Blair media (1) Flocked swabs with LIM Broth media (1) Flocked swabs with VICUM media (6) Flocked swabs with Virus media (1) Human DNAsa, RNAsa and DNA free certified dry swab (2) Meat sampling kit (1) Meat sampling template (1) Surface sampling template (1) Thioglycolate media Selenite Broth (1) Transport swabs with Amies media (5) Transport swabs with Cary Blair media (2) Transport swabs with Stuart media (3) Transport swabs with Virus media (2) Transport swabs with liquid Amies media (1) Transport swabs with media for Chlamydia (1) Transport swabs with media for virus (2) Transport swabs with neutralising Broth (2)
Aluminium (8) Aluminium (twisted) (2) Polypropylene (1) Polystyrene (34) Wood (11) n/a (5)
Cotton (16) Flocked polyester (1) Polyester (20) Pure cotton (1) Viscose (17) Without swab (1) n/a (5)
Flow-pack (4) In bulk (5) In polypropylene tube (12) Peel-pack (37) n/a (3)
Not sterile (7) Sterile (54)