25.09.2023
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: Diode laser hair removal machine for medical use manufactured by Beijing Lead Beauty S & T Co. Ltd., People’s Republic of China, if they have come into possession of the falsified copy of CE certificate of conformity no. G1 005392 0002 Rev. 01 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2020-02-17, valid until 2024-05-26 for this manufacturer.
The valid certificate, with the same identification data, namely number, issuance and expiry date and medical devices categories ‘Diode laser hair removal machine for medical use, Intense pulsed light therapy device (IPL) for medical use’, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), for manufacturer Beijing Nubway S & T Co., Ltd., People’s Republic of China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Diode laser hair removal machine for medical use from manufacturer Beijing Lead Beauty S & T Co. Ltd., People’s Republic of China, 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 on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Baza de date cu certificate:
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