28.02.2022
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 Oxigen Mask, Non-Rebreath Mask, Multi-vent Mask, Stomach Tube, Suction Catheter, Feeding Tube, Nasal Oxygen Cannula, Urethral Catheter without Balloon, Tracheostomy Mask, Aerosol Mask, Nebulizer, Disposable Air Cushion Face Mask, Nasal Jet Tube, Cricothyrotomy Kit, manufactured by Suzhou Ao Tech Co., Ltd., China, if they have come into possession of the falsified copy of the CE certificate of conformity no. G1 038800 0014 Rev.00 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-03-31, valid until 2024-05-26.
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.