08.05.2024
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: ’Dental Unit’ manufactured by Foshan Hongke Medical Instrument Factory, China, for which they have come into possession of the falsified copy of the EC 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 this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Dental Unit’ from manufacturer Foshan Hongke Medical Instrument Factory., China, based on the falsified copy of the CE 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, was issued for the same product categories by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-07-10 and was withdrawn on 2022-05-16 upon manufacturer’s request.
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 Database of falsified certificates at the following link
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate.