23.03.2023
To the attention of all importers, distributors and users of medical devices
The National Agency for Medicines and Medical Devices of Romania warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type ”Sterile Gauze Swab with X-Ray, Sterile Lap Sponge, Sterile Surgical Gloves, Foley Catheter (Latex), Nelaton Catheter, Endotracheal Tubes, Disposable Syringes, Disposable Infusion Sets, Disposable Blood Transfusion Sets, Disposable Scalp Vein Sets, Disposable Hypodermic Needles, Disposable Surgical Blades, Sterile Scalpel with Plastic Handle, Suction Catheter, Feeding Tube, Stomach Tube, Extension Tube/Connecting Tube”, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2.054580.0019.Rev.01, valid from 2019-09-04 to 2024-05-26, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), for any other manufacturer except for Hygeia Medical Co., Ltd., Shanghai, People’s Republic of China.
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 Hygeia Medical Co., Ltd., Shanghai, People’s Republic of China.
If you have come into possession of such medical devices, for which you were shown the falsified copy of the CE certificate of conformity no. G2.054580.0019.Rev.01, 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
