02.10.2023
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 Patient Monitoring Devices, Defibrillator/Monitor, Electrocardiograph, Anesthesia Machine, Ultrasonic Diagnostic Equipment, Digital radiography System manufactured by PT. Mindray Medical Indonesia, Indonesia, if they have come into possession of the falsified CE certificate of conformity no. G1 10 08 44751 054 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 2020-09-17, valid until 2025-02-21 for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Patient Monitoring Devices, Defibrillator/Monitor, Electrocardiograph, Anesthesia Machine, Ultrasonic Diagnostic Equipment, Digital radiography System from manufacturer PT. Mindray Medical Indonesia, Indonesia, 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.
We would like to warn interested parties that, according to the information held by the NAMMDR, in addition to the above-mentioned falsified certificate, the following falsified certificates exist on the EU market as well, for this manufacturer:
– Certificate no. S 951 11 4754 which would have been issued by Notified Body TUV SUD AMERICA INC. on 4 Octombrie 2022, valid until 31 August 2025, in accordance with the requirements of ISO 9001:2008 quality management system for Design and Development, Production and Distribution of Medical Electronic Equipment (including Patient Monitor and Accessories, Defibrillator/Monitor and Accessories, Electro-Cardiograph, Anesthesia Machine and Accessories, Ventilator, Ultrasonic Diagnostic Equipment and Accessories, Digital Radiography System, Magnetic Resonance Imaging System, Hematology Analyzer, Clinical Chemistry Analyzer and Microplate Reader, Microplate Washer for invitro Diagnostic use), Reagents for Hematology Analyzer, Reagents for Clinical Chemistry Analyzer
– Certificate no. Q1N 11 05 44751 057 which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123), on 01.09.2022, valid until 31.08.2025, in accordance with the requirements of standard EN ISO 13485:2016 for Design and Development, Production and Distribution of Medical Electronic Equipment (including Patient Monitor and Accessories, Defibrillator/Monitor and Accessories, Electrocardiograph, Anesthesia Machine, Ventilator, Ultrasonic Diagnostic Equipment and Accessories, Digital Radiography System, Hematology Analyzer, Clinical Chemistry Analyzer and Microplate Reader, Microplate Washer for in-vitro diagnostic use), Reagents for Hematology Analyzer, Reagents for Clinical Chemistry Analyzer
For personal verification, we recommend that interested parties consult the information on the website of Notified Body, TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Baza de date cu certificate:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank
Database of falsified certificates:
https://www.tuvsud.com/de-de/dienstleistungen/produktpruefung-und-produktzertifizierung/zertifikatsdatenbank/tuev-sued-pruefzeichen/liste-gefaelschter-zertifikate
National Agency for Medicines and Medical Devices of Romania
