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 ‘Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold test’ accompanied by a falsified copy of CE certificate of conformity no. V1 084924 0002 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2018-11-30 and valid until 2025-10-10.
The valid CE Certificate of Conformity with No. V1.084924.0002.Rev.01 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-11-30, valid until 2023-10-10 for ‘Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold’ test and belongs to manufacturer Hubei MEIBAO Biotechnology Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell ‘Human chorionic gonadotropin Colloidal gold test, Human Luteinizing hormone Colloidal gold test, Fecal Occult Blood Colloidal gold test’ on the Romanian territory based on the falsified copy of the CE certificate of conformity no. V1.084924.0002.Rev.01, 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