29.01.2026
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 Computed Tomography Scanner Systems, X-ray Imaging Systems, Magnetic Resonance Imaging Systems, Positron Emission Tomography(PET) and Computed Tomography(CT) Systems, Diagnostic Ultrasound Systems, Diagnostic X-ray High Voltage Generators, Picture Archiving and Communication Systems accompanied by a falsified copy of CE certificate of conformity no. G1.098883.0002.Rev.02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2024-06-03 and valid until 2026-06-02.
The valid CE Certificate of Conformity with No. G1.098883.0002 Rev.02 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-09-03, valid until 2024-05-26 for ‘Computed Tomography Scanner Systems, X-ray Imaging Systems, Magnetic Resonance Imaging Systems, Positron Emission Tomography(PET) and Computed Tomography(CT) Systems, Diagnostic Ultrasound Systems, Diagnostic X-ray High Voltage Generators, Picture Archiving and Communication Systems’ and belongs to manufacturer Neusoft Medical Systems Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Computed Tomography Scanner Systems, X-ray Imaging Systems, Magnetic Resonance Imaging Systems, Positron Emission Tomography(PET) and Computed Tomography(CT) Systems, Diagnostic Ultrasound Systems, Diagnostic X-ray High Voltage Generators, Picture Archiving and Communication Systems’ on Romanian territory, based on the falsified copy of the CE certificate of conformity no. G1.098883.0002 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 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
