19.06.2025
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 medical devices of type ‘Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags’ accompanied by the falsified CE certificate no. Q6 073425 0011 Rev. 02, which would have been issued by Notified Body TÜV SÜD Product Service GmbH (0123) on 2022-09-06 and valid until 2025-09-05.
The valid certificate with the same identification data, namely number, product categories, issue and expiry date belongs to manufacturer Jiangsu Zhengkang Medical Apparatus Co., Ltd., China and was issued by Certifying Body TÜV SÜD Product Service GmbH, Germany in accordance with the requirements of standard EN ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes for ‘Production and Distribution of Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags’.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory ‘Infusion Sets for Single Use (with Needle), Sterile Hypodermic Syringes for Single Use (with Needle), Disposable Sterile Hypodermic Needles, Scalp vein Sets, Sterile Insulin Syringes for Single Use, Disposable Transfusion Set (with Needle), Urine Collection Bags’ based on the falsified copy of certificate no. Q6 073425 0011 Rev. 02, 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 your own 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
