21.06.2024
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: ’UNIQA Dental Implants- Systems: Dental Implants, Dental Abutments and Superstructures’ manufactured by UNIQA Dental Ltd., Israel, for which they have come into possession of the falsified copy of the EC certificate of conformity no. D1437000001 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483) on 2023-02-18, valid until 2028-02-18 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’UNIQA Dental Implants- Systems: Dental Implants, Dental Abutments and Superstructures’ from manufacturer UNIQA Dental Ltd., Israel, 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, had the same number, was issued by Notified Body mdc medical device certification GmbH, Germany (0483) on 2019-02-18 and was valid until 2023-02-18 for the same product categories.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body mdc medical device certification GmbH, Germany (0483) by accessing this link:
https://www.mdc-ce.de/downloads/mdc-documents/lists-of-certificates.html?L=