31.03.2023
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 on the Romanian market medical devices of type Blood separating kit, manufactured by Glofinn Co., Ltd., Republic of Korea, if they have come into possession of the falsified CE certificate of conformity no. G1.098601.0004.Rev.00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2022-08-10, valid until 2024-08-10 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Blood separating kit from manufacturer Glofinn Co., Ltd., Republic of Korea, do not place them on the market 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 posted 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
National Agency for Medicines and Medical Devices of Romania
