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: ’Dental Suction Systems’ manufactured by Suzhou Junwei Medical Equipment Co., Ltd., China, if they have come into possession of the falsified EC certificate of conformity no. G2 18 04 82113 008 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2023-05-25, valid until 2025-05-24, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Dental Suction Systems from manufacturer Suzhou Junwei Medical Equipment Co., Ltd., China, based on the falsified certificate, 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.
Atragem atenția părților interesate că, potrivit informațiilor intrate în posesia ANMDMR, în afara certificatului falsificat mai sus menționat, pentru acest producător mai există pe piața UE și certificatul falsificat nr. Q8 082551 0003 Rev. 01 which would have been issued by Certifying Body TÜV SÜD Product Service GmbH, Germany on 2022-04-25, valid until 2025-04-24 in accordance with the requirements of standard EN ISO 13485:2016 – Quality management systems. Requirements for regulatory purposes for Design and Development, Production and Distribution of Medical Oil Free Air Compressors, Dental Suction Systems.
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
