29.08.2025
To the attention of all interested parties
According to the information received by the ANMDMR, counterfeit medical devices originating from a distributor in China have been identified on the Vietnamese market.
The discrepancies identified by manufacturer Thermoplastic Comfort Systems, Inc., USA in the counterfeit TCS Unbreakable Dental Resin medical devices consist of:
1. The presence of the CE marking on the label, followed by the number of the Notified Body “National Standards Authority of Ireland, Ireland” (0050), while the original medical devices are classified as class I and contain only the CE marking on the label.
2. The entire label, packaging configuration and information distribution differ from the original medical devices.
3. The label of the counterfeit medical devices was copied from previous versions of the label of the original medical devices, when the product required the involvement of a notified body in view of being placed on the market, and the CE marking followed by the notified body number was on the label.
If you have come into possession of counterfeit medical devices of the type mentioned above or if you are aware of distributors selling such devices on the Romanian territory, do not use them and notify the National Agency for Medicines and Medical Devices of Romania at the contact details posted on the ANMDMR website.