10.04.2023
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 on the Romanian market medical devices of type: Product for determination of infection markers Model/(s) In-Vetro Diagnostic Medical Device for Detection of SARS-CoV-2 Antibody (colloidal gold immunochromatography) Model: COVID19 INSTATEST (Self-testing: 1 test per box), manufactured by Beijing Lepu Medical Technology Co. Ltd., China, if they have come into possession of the falsified CE certificate of conformity no. V1.18.02.03496.002 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2020-03-13, valid until 2023-06-27 for this manufacturer.
If you have come into possession of such in vitro diagnostic medical devices or are aware of distributors who sell on the Romanian territory these types of devices based on the aforementioned falsified certificate, do not use them or make them available on the market 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.
For personal verification, we recommend that interested parties consult the information posted 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