02.02.2026
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 ‘Dental Unit’ if, for these medical devices, they have come into possession of the falsified copy of the CE certificate of conformity no. G2 17 02 83445 004 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-07-10, valid until 2025-07-09, for any other manufacturer except for Foshan Hongke Medical Instrument Factory, China.
The valid CE Certificate of Conformity with No. G2 17 02 83445 004 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-07-10, valid until 2022-07-09 for ‘Dental Unit’ and belongs to manufacturer Foshan Hongke Medical Instrument Factory, China.
If you have come into possession of such medical devices for which you were shown the falsified copy of the CE certificate of conformity no. G2 17 02 83445 004, 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 the 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 issued 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
