23.01.2024
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 medical devices of type ’dental products, otoplastic products – cavity cleaning liquid; resins for the fabrication of otoplastics; dental cements; materials for the manufacturing of temporary crowns and bridges; one-component material, light curing; composite-based fissure sealant, light curing; permanently soft denture relining materials; epithesis material; protective lacquer for root dentine; dental moldings’, manufactured by DETAX GmbH & Co. KG, Germany, if they have come into possession of the falsified copy of the CE certificate of conformity no. D1002700048 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483) on 25.04.2023 valid until 20.04.2026 for this manufacturer.
The valid certificate issued by Notified Body mdc medical device certification GmbH, Germany (0483) for manufacturer DETAX GmbH & Co. KG, Germany has the same identification number and different dates of issue and expiry, 05.05.2021 and 26.05.2024.
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. D1002700048 , 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 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=