28.05.2024
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: ’Patient Monitoring Devices, Vital Signs Monitor, Center Monitoring System, Telemetry Monitoring System, Ambulatory Blood Pressure Monitor, Pulse Oximeter, Temperature Probe, SPO2 Sensors, External Defibrillator Paddles, Anaesthetic Vaporizer, Defibrillator/Monitor, Electrocardiograph, Wearable ECG Recorder, Anesthesia Machine, Ventilator, Ultrasonic Diagnostic Equipment, Ultrasonic Transducer, Digital Radiography System, Radiography System, Magnetic Resonance Imaging System’ accompanied by the falsified copy of CE certificate of conformity no. G1 18 03 44751 113, which would have been issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-07-09, valid until 2025-02-21.
The valid CE Certificate of Conformity with No. G1 18 03 44751 113, issued by Notified Body TÜV SÜD Product Service GmbH, Germany (0123) on 2018-07-09, valid until 2020-02-21, for the same product categories, belonged to manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ’Patient Monitoring Devices, Vital Signs Monitor, Center Monitoring System, Telemetry Monitoring System, Ambulatory Blood Pressure Monitor, Pulse Oximeter, Temperature Probe, SPO2 Sensors, External Defibrillator Paddles, Anaesthetic Vaporizer, Defibrillator/Monitor, Electrocardiograph, Wearable ECG Recorder, Anesthesia Machine, Ventilator, Ultrasonic Diagnostic Equipment, Ultrasonic Transducer, Digital Radiography System, Radiography System, Magnetic Resonance Imaging System’ based on the falsified copy of certificate no. G1 18 03 44751 113, 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.
For personal verification, we recommend that interested parties consult the information posted on the website of Notified Body TÜV SÜD Product Service GmbH, Germany (0123), by accessing the links below:
Database of issued certificates:
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
