08.05.2024
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: Autoclave, Hydrogen peroxide plasma sterilizer, Ethylene oxide sterilizer, Low temperature steam formaldehyde sterilizer, Washer-disinfector manufactured by Hongshun Medical Instrument Co., Ltd., China for which they have come into possession of the falsified CE certificate of conformity no. G1 041505 0125 Rev. 00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2024-01-17, valid until 2029-01-16, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Autoclave, Hydrogen peroxide plasma sterilizer, Ethylene oxide sterilizer, Low temperature steam formaldehyde sterilizer, Washer-disinfector from manufacturer Hongshun Medical Instrument Co., Ltd., China, based on the falsified certificate, 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 Database of falsified certificates at the following link
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate.