29.08.2025
To the attention of all interested parties
According to the information obtained by the NAMMDR, counterfeit medical devices originating from a distributor in China have been identified on the Vietnamese market.
The discrepancies identified by the manufacturer Thermoplastic Comfort Systems, Inc., USA in TCS Unbreakable Dental Resin counterfeit medical devices consist of:
1. The presence on the label of the CE marking followed by the number of the notified body National Standards Authority of Ireland, Ireland (0050), while original medical devices are classified as Class I and contain only the CE marking on the label.
2. The whole label, packaging configuration and distribution of information differ from the original medical devices.
3. The label of the counterfeit medical devices was copied from previous versions of the original medical devices, when the product required the involvement of a notified body in order to be placed on the market, and the CE marking followed by the notified body’s number was on the label.
If you own counterfeit medical devices of the aforementioned type or if you are aware of distributors who sell such devices on the territory of Romania, please do not use them and notify the National Agency for Medicines and Medical Devices of Romania at the contact details available on the NAMMDR website.