24.09.2021
To the attention of all importers and distributors of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of type DIAVUE ToGo Blood Glucose Monitoring System (including blood glucose meter, blood glucose test strips and control solutions), manufactured by BioCare Corporation, Taiwan, if they have come into possession of falsified certificate no. V1 077360 0016 Rev, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) for this manufacturer and device, on 2019-04-08, valid until 2022-01-22.
To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95/2006 on healthcare reform, republished, as further amended and supplemented.