13.12.2023
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: ’Medical Natural Rubber Latex Examination Glove’, ‘Examination Synthetic Rubber Latex Examination Glove’, ‘Disposable Synthetic Rubber Latex Surgical Glove’, manufactured by Ace Glove(M) Sdn. Bhd., Malaysia, if they have come into possession of the falsified copy of certificate no. Q5 055729 0012 Rev.01 which would have been issued by Certifying Body TÜV SÜD Product Service GmbH, Germany, in accordance with the requirements of standard EN ISO 13485:2016 – Quality management systems, QMS regulatory requirements, on 2023-05-01, valid until 2026-04-30, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Medical Natural Rubber Latex Examination Glove, Examination Synthetic Rubber Latex Examination Glove, Disposable Synthetic Rubber Latex Surgical Glove from manufacturer Ace Glove(M) Sdn. Bhd., Malaysia, 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.
The valid certificate with the same identification data, namely number, issue and expiry date was issued by Certifying Body TÜV SÜD Product Service GmbH, Germany for manufacturer Top Glove Sdn. Bhd. Malaysia, for:
– Design and Development, Manufacture and Distribution of:
1. Non-Sterile Natural Rubber Latex Examination Glove
2. Non-Sterile Synthetic Rubber Latex Examination Glove
– Manufacture and Distribution of:
1. Sterile Synthetic Rubber Latex Surgical Glove.
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:
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
