23.01.2026
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 ‘Sterile Non-active Medical Devices’ manufactured by Guangzhou AMK Medical Equipment Co., Ltd., China for which they have come into possession of the falsified copy of the EC certificate of conformity no. G2 001281 0001 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2021-04-29 and valid until 2025-05-26 for this manufacturer.
The valid CE Certificate of Conformity with No. G2 001281 0001 Rev. 02 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-04-29, valid until 2024-05-26 for Sterile Non-active Medical Devices and belongs to manufacturer Guangzhou AMK Medical Equipment Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell Sterile Non-active Medical Devices on the Romanian territory based on a falsified copy of certificate no. G2 001281 0001 Rev.02, 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 your own 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
