19.04.2022
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 Wrist Type Blood Pressure Monitor, Infrared Thermometer, Arm Type Blood Pressure Monitor, Fetal Doppler, Nebulizer, manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd., China, if they have come into possession of a falsified copy of the EC certificate of conformity no. G2 092582 0010 Rev. 00, issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-11-26, valid until 2024-05-26, copy which includes all the aforementioned medical devices.
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
TÜV Rheinland LGA Products GmbH, Germany (0197)
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, to permanently consult the NAMMDR website for such information and to ensure 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.