19.08.2024
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: ’Radio-Frequency assisted liposuction systems’ accompanied by the falsified copy of CE certificate of conformity no. 2120853CE01, which would have been issued by Notified Body DEKRA certification B.V., The Netherlands (0344) on 2022-02-01, revised on 2023-01-22 and valid until 2026-02-01.
The valid CE Certificate of Conformity with No. 2120853CE01, issued by Notified Body DEKRA certification B.V., The Netherlands (0344), on 2018-02-01, revised on 2020-01-27 and valid until 2023-02-01, for the same product categories, belongs to manufacturer InMode Ltd., Israel.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Radio-Frequency assisted liposuction systems’ based on the falsified copy of certificate no. 2120853CE01, 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.
National Agency for Medicines and Medical Devices of Romania
