07.08.2023
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: Hip Implants, Bipolar Head manufactured by OHST Medizintechnik AG, Germany, if they have come into possession of the Falsified CE design examination certificate no. 13434GB411150818, which would have been issued by Notified Body MEDCERT GmbH , Germany (0482), on 2020-08-18, valid until 2030-12-22 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Hip Implants, Bipolar Head from manufacturer OHST Medizintechnik AG, Germany, based on the falsified certificate previously mentioned, 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.