30.10.2023
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: Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) manufactured by Prolinx GmbH, Germany, if they have come into possession of the falsified CE certificate of conformity no. N50569-15-8 which would have been issued by Notified Body mdc medical device certification GmbH, Germany (0483), on 2021-08-18, valid until 2024-07-02 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Blood glucose monitoring systems (B12, B12 LAEN, B13, B14, B15, B16, B17, B18, B19) from manufacturer Prolinx GmbH, Germany, 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 the link below:
https://www.mdc-ce.de/downloads/mdc-documents/lists-of-certificates.html