09.05.2024
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: ’Intense Pulsed Light for medical use + Diode Laser Equipment for medical use, CO2 Fractional Laser Equipment for medical use’ manufactured by Beijing Globalipl Development Co., Ltd., China, for which they have come into possession of the falsified copy of the CE certificate of conformity no. G1 002325 0002 Rev. 01, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2023-10-28, valid until 2027-12-31.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Intense Pulsed Light for medical use + Diode Laser Equipment for medical use, CO2 Fractional Laser Equipment for medical use’ from manufacturer Beijing Globalipl Development Co., Ltd., China, based on the falsified copy of the CE 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 initially issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-12-07, valid until 2023-10-27, 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
