Ready for the European market.
Regulation (EU) 2017/745
Class I medical devices. CE marking affixed under Article 52(7) for our non-sterile nitrile and latex examination gloves.
EU Declarations of Conformity VG-DOC-LTX-001 and VG-DOC-NBR-001 (Rev 1.0) are available on request.
Manufacturer SRN EG-MF-000060464
Our manufacturer registration and eight devices — latex and nitrile examination gloves in sizes S, M, L and XL — are registered in EUDAMED. Verify them on the official EUDAMED site with our SRN.
Basic UDI-DI · Latex 6225001LTXEXAMWQ · Nitrile 6225001NBREXAMNE
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo N18, 29006 Malaga, Spain
SRN ES-AR-000000293
ISO 13485:2016 · ISO 9001:2015
Certified to ISO 13485:2016 (MSE 0870725MD) and ISO 9001:2015 (065575-A).
EN 455-1, -2 and -3
Manufactured and tested to EN 455-1, -2 and -3. Every batch is released by our in-house EN 455 quality laboratory, and pre-shipment inspection is available.
Examination gloves
Our CE marking covers non-sterile examination gloves. Sterile surgical gloves, coming 2027, follow their own conformity route under Regulation (EU) 2017/745, which forms part of the programme for this line.
Certified to ISO 13485:2016 (MSE 0870725MD) and ISO 9001:2015 (065575-A). Manufactured and tested to EN 455-1, -2 and -3. CE marking affixed under Regulation (EU) 2017/745, Article 52(7). Manufacturer SRN EG-MF-000060464. EU Authorised Representative: CMC Medical Devices & Drugs S.L., C/ Horacio Lengo N18, 29006 Malaga, Spain, SRN ES-AR-000000293.