24.05.2021
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 Thermometer, Pulse Oximeter, signs Monitor, Multiparameter Patient Monitor, manufactured by HEYUAN LEYUAN INTELLIGENT TECHNOLOGY CO.,LTD, China, if they have received the falsified EC certificate of conformity no. G1 076561 0010 Rev.00, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2020-03-02, valid until 2024-05-26.
Or personal verification of the validity of the EC Certificate of Conformity held, we recommend checking the information contained in the following notification, posted on the NAMMDR website, section IMPORTANT NOTIFICATION – MEDICAL DEVICES:
04.09.2020
To the attention of all stakeholders (contracting healthcare units, importers and distributors of medical devices and so on)
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.