18.12.2023
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: ’Latex Gloves, Vinyl Gloves, Nitrile Gloves (For single use)’ manufactured by Taiyu Gloves CO., Limited, China, if they have come into possession of the falsified CE certificate of conformity no. G2S 08 09 64733 008 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2022-11-29, valid until 2025-11-28 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Latex Gloves, Vinyl Gloves, Nitrile Gloves(For single use)’ from manufacturer Taiyu Gloves CO., Limited, China, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate