31.03.2023
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: Infusion Pump, Syringe Pump Infusion Warmer, Patient Warming Machine, manufactured by Jiangsu Sinowise Technology Co., Ltd., People’s Republic of China, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1.104715.0002.Rev.01 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2021-04-23, valid until 2024-05-26 for this manufacturer.
The valid certificate with the same identification data, namely number, issue and expiry date and medical device categories Infusion Pump and Syringe Pump, was issued by Notified Body TÜV SÜD Product Service GmbH, Germany(0123), for manufacturer Dongguan HEPHO Medical Science Technology 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 Infusion Pump, Syringe Pump Infusion Warmer, Patient Warming Machine from manufacturer Jiangsu Sinowise Technology Co., Ltd., People’s Republic of China, do not place them 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:
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