21.05.2021
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 Nitrile examination gloves, manufactured by Guangzhou Pidegree Medical Technology Co., Ltd., China, if they have received the falsified EC certificate of conformity no. 6706GB415100225, which would have been issued by Notified Body MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH, Germany (0482) on 2020-02-25, valid until 2025-11-09, in line with Annex II – Essential Requirements according to the PPE-Directive 89/686/EEC.
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, please check the NAMMDR website for such information 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.