21.06.2024
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: ’Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner’ manufactured by Sonostar Technologies Co., Ltd., China, for which they have come into possession of the falsified copy of the EC certificate of conformity no. G1 095448 0004 Rev. 00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-08-30.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Diagnostic Ultrasound Systems, Wireless Probe Type Ultrasound Scanner’ from manufacturer Sonostar Technologies 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, had the same number, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2017-06-22, supplemented on 2018-08-30, was valid until 2022-06-21 and covered 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
