02.08.2022
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 the types of medical devices manufactured by Divine Medicure Technology, India, which are the subject of the falsified EC Certificate of Conformity no. 245067-2019-CE-IND-NA-PS Rev. 0.0 which would have been issued by Notified Body DNV GL Presafe AS, Norway (2460) on 15 April 2019, valid until 10 December 2023.
According to information received by the NAMMDR, Notified Body DNV GL Presafe AS, Norway (2460) has not issued any CE Certificate of Conformity for this manufacturer.
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.