23.03.2023
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 on the Romanian market medical devices of type: Disposable Anesthesia Needle and Anesthesia Kit, manufactured by YangZhou SUSMED IMPORT&EXPORT CO.,LTD., China, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1.17.12.82107.013 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-05-07, valid until 2023-05-06 for this manufacturer.
The valid certificate, with the same identification data, namely number, medical device category, issue and expiry date, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), for manufacturer Zhejiang Runqiang Medical Instruments Co., Ltd., People’s Republic of China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Disposable Anesthesia Needle and Anesthesia Kit from manufacturer YangZhou SUSMED IMPORT&EXPORT CO.,LTD., China, do not use them or make them available on the market 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:
Baza de date cu certificate:
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
