08.08.2024
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: Hyperbaric Oxygen Treatment Systems (Hyperbaric Oxygen Chamber) – Multiplace Omega, Multiplace Cylindirical, Multiplace Quadro, Monoplace accompanied by falsified CE certificate no. 2195-MED-401431701 which would have been issued by Notified Body Szutest Uygunluk Değerlendirme A.Ş., Turkey (2195) on 2014-11-13, revised on 2019-11-12 and valid until 2025-05-26 for manufacturer Oxycare Prefabrik Mobil Çözümler Sanayi İthalat İhracat Ticaret Limited Şirketi, Turkey.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Hyperbaric Oxygen Treatment Systems (Hyperbaric Oxygen Chamber) – Multiplace Omega, Multiplace Cylindirical, Multiplace Quadro, Monoplace, 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.