12.12.2022
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: Integral Dental Unit, manufactured by Foshan Nanhai Hager Medical Machinery Co., Ltd., PEOPLE’S REPUBLIC OF CHINA if they have come into possession of the falsified copy of the CE certificate of conformity no. G2 058482 0010 Rev. 00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-07-07, valid until 2025-07-06 for this manufacturer.
The valid certificate, with the same number and for the same medical device category, issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) belongs to manufacturer Foshan Anle Medical Apparatus Co., Ltd., People’s Republic of China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Integral Dental Unit from manufacturer Foshan Nanhai Hager Medical Machinery Co., Ltd., PEOPLE’S REPUBLIC OF CHINA, do not use them or make them available 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 interested parties to check this information 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
