30.03.2026
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 ‘Fetal Dopplers, Pulse Oximeters, Nebulizers and Infrared Thermometers’ accompanied by a falsified copy of CE certificate of conformity no. G1 073767 0013 Rev. 00, presumably issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2021-02-03 and valid until 2026-02-02.
The valid CE Certificate of Conformity with No. G1 073767 0013 Rev. 00, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-02-03, valid until 2024 -02-02 for ‘Fetal Dopplers, Pulse Oximeters, Nebulizers and Infrared Thermometers’ and belongs to manufacturer Shenzhen Aeon Technology Co. Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Fetal Dopplers, Pulse Oximeters, Nebulizers and Infrared Thermometers ‘ on the Romanian territory, based on a falsified copy of certificate no. G1 073767 0013 Rev. 00, 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
