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: Hyaluronan Soft Tissue Filling Gel – Manorui Cross Linked / Non Cross Linked Hyaluronic Acid, manufactured by Jining Hangxing E-Commerce Co., Ltd., China if they have come into possession of the falsified copy of the EC certificates of conformity no. 2020-MDD/QS-008 in line with Annex II, Section 4 excluded, of Directive 93/42/EEC and no. 2020-MDD/DE-025 in line with Annex II, Section 4 of Directive 93/42/EEC which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) on 2020-11-07, valid until 2025-11-06.
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/.