27.05.2022
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:
– Video Laryngoscope, manufactured by KoMaC Co. Ltd., Korea, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 075408 0030 Rev.03, issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-11-21, valid until 2024-05-26.
– Bronchoscope, manufactured by KoMaC Co. Ltd., Korea, if they have come into possession of the falsified copy of the CE certificate of conformity no. G2S 073403 0028, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2019-12-31, valid until 2024-12-30.
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, to permanently consult the NAMMDR website for such information and to ensure 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.