27.09.2023
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 or make available on the Romanian market medical devices of type ’One Step Rapid Diagnostic Step – One Step HBsAg Test (Strip B11-11, Cassette B11-20), One Step HCV Test (Strip B20-11, Cassette B20-20), One Step HIV 1+2Test (Strip C10-11, Cassette C10-20)’, if they have come into possession of a falsified copy of the EC Certificate of Conformity no. 2022-IVD/QS-007 for these medical devices, which would have been issued by Notified Body 3EC International a.s., Slovakia (2265) on 25 Mai 2022 valid until 26 Mai 2025.
The valid certificate with the same identification data, namely number, product categories, issue and expiry date One Step Rapid Diagnostic Test – CoretestsOne Step HBsAg Test (Strip B11-11, Cassette B11-20), CoretestsOne Step HCV Test (Strip B20-11, Cassette B20-20), CoretestsOne Step HIV 1+2 Test (Strip C10-11, Cassette C10-20) was issued by Notified Body 3EC International a.s., Slovakia (2265) for manufacturer Core Technology Co., Ltd., 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. 2022-IVD/QS-007, 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 this information posted on the website of Notified Body 3EC International a.s., Slovakia (2265), by accessing the link below:
Database of falsified certificates: https://www.3ec.sk/en/services/falsificates/
National Agency for Medicines and Medical Devices of Romania
