18.06.2025
To the attention of all importers, distributors and users of medical devices
18.06.2025
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 medical devices of type ‘Pulse Oximeter, SPO2 Sensor, Patient Monitor’ accompanied by a falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2024-05-15 and valid until 2028-12-31.
The valid CE certificate of conformity with no. G1 087056 0005 Rev. 02 was issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2019-05-16, valid until 2024-05-15, for ‘SPO2 Monitor, Pulse Oximeter, Spo2 Sensor, Patient Monitor’ and belongs to manufacturer Shanghai Berry Electronic Tech Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Pulse Oximeter, SPO2 Sensor, Patient Monitor’ on the Romanian territory based on the falsified copy of CE certificate of conformity no. G1 087056 0005 Rev. 02, 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.
For your own 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
