30.01.2024
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: ’Blood Collection Needles for Single Use, Disposable Blood Lancets, Disposable Safety Lancets’ manufactured by Liuyang Sanli Medical Technology Development Co.,Ltd., China, for which they have come into possession of the falsified copy of the EC certificate of conformity no. G2 099529 0002 Rev. 00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-07-31, valid until 2024-07-30 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Blood Collection Needles for Single Use, Disposable Blood Lancets, Disposable Safety Lancets’ from manufacturer Liuyang Sanli Medical Technology Development 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.
The valid certificate held by this manufacturer has the same number and was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 31.07.2018, valid until 30.07.2023 for the same product categories.
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
National Agency for Medicines and Medical Devices of Romania
