04.08.2021
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 type Oxygen concentrator – product name: LG102P, LG103, manufactured by Oxytek Medical Technology Co., Ltd., China, if they have received the falsified EC certificate of conformity no. 10014-2017-CE-RGC-NA-PS Rev 0.0 which would have been issued by Notified Body DNV GL Presafe AS, Norway (NB 2460) on 31.07.2018, valid until 31.07.2023.
The valid certificate with no. 10014-2017-CE-RGC-NA-PS Rev 0.0 was issued by Notified Body DNV GL Presafe AS, Norway (NB 2460) for this manufacturer, on 31.07.2017, valid until 31.07.2022 and does not specify the LG102P and LG103 types of concentrators.
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.