21.04.2021
To the attention of all importers and distributors of medical devices
The National Agency for Medicines and Medical Devices warns all importers and distributors of medical devices not to introduce on the Romanian market medical devices of types Hy-Silk™ Light, Hy-Silk™ Deep, Hy-Silk™ Ultra Deep and Crosslinked Hyaluronic Acid With Lidocaine With provision for Inclusion of Biocompatible Materials less than 2% Weight, manufactured by +Biio-P Pharmaceutical Manufacturing, Korea, if they have come into possession of the falsified CE certificates of conformity no. 1434-MDD-327/2020 and no. 1434-MDD-328/2020, which would have been issued by Notified Body Polish Centre for Testing and Certification, Poland (1434), valid from 27.08.2020 to 27.05.2024.
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, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices 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.