09.11.2022
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: A set of silicone devices for gastric restriction- MediStars Intragastric Balloon, manufactured by JSC “MediStars”, Russia if they have come into possession of the falsified copy of the CE certificate of conformity no. 2019-MDD/QS-033 which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) on 2019-04-26, valid until 2024-04-25.
For personal verification, we recommend interested parties to check this information on the website of Notified Body 3EC International a.s., Slovakia (2265), by accessing the link below:
Database of falsified certificates: https://www.3ec.sk/en/services/falsificates/.