14.12.2023
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: ’Disposable Latex Surgical Gloves, Disposable Latex Examination Gloves’ manufactured by Pidegree Industrial Co.,Limited., China, if they have come into possession of the falsified copy of the EC certificate of conformity no. G2 074980 0012 Rev. 01 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-03-04, valid until 2024-05-26 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Disposable Latex Surgical Gloves’, ‘Disposable Latex Examination Gloves’ from manufacturer Pidegree Industrial Co., Limited., China, 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.
The valid certificate with the same identification data, namely number, date of issue and expiry and belonging to product category ‘Disposable Latex Surgical Gloves’, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), for manufacturer Tianchang Hengsheng Medical Devices Co.,Ltd., China.
For personal verification, we recommend that interested parties consult the information on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate
National Agency for Medicines and Medical Devices of Romania
