30.01.2024
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 in vitro diagnostic medical devices of type: ’FinесаrеTM Fully-Automatic FlA Analyzer’ manufactured by Guangzhou Wondfo Biotech Co., Ltd., China, for which they have come into possession of the falsified copy of the EC certificate of conformity no. V74 058008 0034 Rev. 00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2021-08-12, valid until 2024-04-20 for this manufacturer.
If you have come into possession of such in vitro diagnostic medical devices or are aware of distributors who sell: ’FinесаrеTM Fully-Automatic FlA Analyzer’ from manufacturer Guangzhou Wondfo Biotech Co., Ltd., China, on Romanian territory, based on the falsified certificate, 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.
The valid certificate held by this manufacturer has the same number and was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2021-08-12 and is valid until 2026-08-11 for the following product categories:
FinecareTM CRP Test W201P0010
FinecareTM CRP Test W201P0011
FinecareTM HbA1c Test W207-C7PM
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
