26.01.2024
To the attention of all importers, distributors and users of medical devices
The NAMMDR warns all importers and distributors of medical devices not to introduce or make available on the Romanian market: X Ray and accessories; Ultrasound; Laboratory; Operation -room equipment; Dental; Infants Care; Sterilization equipment; Morque supplies; Veterinary equipment manufactured by Guanzhou Yueshen Medical Equipment Co., Ltd., China, for which they have come into possession of the falsified CE certificate of conformity no. 7003GB410160415 which would have been issued by Notified Body DNV MEDCERT GmbH, Germany (0482) on 2020-04-15, valid until 2023-11-06 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory X Ray and accessories; Ultrasound; Laboratory; Operation -room equipment; Dental; Infants Care; Sterilization equipment; Morque supplies; Veterinary equipment from manufacturer Guanzhou Yueshen Medical Equipment Co., Ltd., China, based on the falsified certificate, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact details posted on the NAMMDR website.