18.06.2025
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 ‘Ligation Clips for Single Use’ accompanied by a falsified copy of CE certificate of conformity no. HD 60104799 0001, which would have been issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2023-02-02 and valid until 2028-01-01.
The valid CE Certificate of Conformity with No. HD 60104799 0001, issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2015-11-02, valid until 2018-06-03, for the same product category, belonged to manufacturer Tonglu Zhouji Medical Instrument Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Ligation Clips for Single Use’ on the Romanian territory based on a falsified copy of the EC certificate of conformity no. HD 60104799 0001, 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 your own verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197), by accessing the links below:
– database with valid certificates: https://www.certipedia.com/?locale=en
– database with falsified certificates: https://www.tuv.com/world/en/warning-list/