02.11.2021
To the attention of all importers and distributors of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type Auto Disable Syringes, Burette Infusion Set; Insulin Syringes for Single Use, face Masks, manufactured by Changzhou Medical Appliances General Factory Co., Ltd., China, for which a falsified copy of the EC Certificate of Conformity No. DD 2183016-1 was detected on the EU market, issued by Notified Body TÜV Rheinland LGA Products GmbH, Germany (0197) on 2020-11-30, valid until 2024-05-26.
For personal verification of the validity of the EC Certificate of Conformity held, we recommend interested parties to verify any information of this kind, posted by the issuing Notified Bodies on their own websites, such as:
TÜV SÜD Product Service GmbH, Germany (0123)
Database of issued certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
(search criterion: second group of digits of the certificate number).
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate
Database of issued certificates:
https://www.certipedia.com/ (search criterion: second group of digits of the certificate number)
Database of falsified certificates:
https://www.tuv.com/world/en/black-list/
To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95/2006 on healthcare reform, republished, as further amended and supplemented.