19.01.2026
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 medical devices type ‘Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread’, manufactured by Bluemed Healthcare Co., Ltd., China, for which they came into possession of the falsified copy of CE certificate of conformity no. G2 17 07 99160 003, which was allegedly issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2017-11-17 and valid until 2024-11-16 for this manufacturer.
The valid CE Certificate of Conformity with No. G2 17 07 99160 003 was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2017-11-17, valid until 2022-11-16 for ‘Infusion Set, Lap Sponges, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Sterile Non-woven Swabs with X-ray Thread’ and belongs to manufacturer Bluemed Healthcare Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Infusion Set, Lap Sponges, Sterile Medication Set, Gauze Swabs without X-ray Thread, Gauze Swabs with X-ray, Non-woven Swabs with X-ray Thread’ based on the falsified copy of certificate no. G2 17 07 99160 003, 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.
Database of issued certificates: 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
