04.10.2022
To the attention of all importers and distributors of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type: Dental Devices, Components and Consumables / types: Lingual Appliances, Self-Ligating Appliances, Ceramic Brackets, Metal Brackets. Digital Orthodontics Buccal Tubes and Bands, Archwire Systems, Bonding Banding Products and Curing Light for Dental Use, manufactured by 3M UNITEK, Germany – 3M UNITEK Orthodontic Products, SUA if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 07 01 50371 003 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 02 June 2015.
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 link below:
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate