24.04.2023
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 on the Romanian market medical devices of type: Oxidized regenerated cellulose – Equicel and Equitamp, manufactured by EQUIMEDICAL BV, the Netherlands, if they have come into possession of the falsified CE certificate of conformity no. 11152-2017-CE-IBE-NA-PS Rev. 2.0 and of the falsified CE certificate of conformity no. 11150-2017-CE-IBE-NA-PS Rev. 2.0, which would have been issued by Notified Body DNV GL NEMKO PRESAFE AS, Norway (2460) on 21 April 2021, valid until 21 April 2026 and 20 April 2026, for this manufacturer.
If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory Oxidized regenerated cellulose – Equicel and Equitamp, manufactured by EQUIMEDICAL BV, the Netherlands, based on falsified certificates, do not use them or make them available on the market, return them to the suppliers 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 draw the attention of all interested parties to the fact that the latest CE certificates of conformity held by this manufacturer for the medical devices in question, namely CE conformity certificate no. 11152-2017-CE-IBE-NA-PS Rev. 1.0 and CE design examination certificate no. 11150-2017-CE-IBE-NA-PS Rev. 1.0, both valid until 04 April 2023 have been suspended by issuing Notified Body (2460) on 28 May 2019 and subsequently withdrawn by issuing Notified Body (2460) on 11 September 2019. If you have come into possession of these medical devices or are aware of distributors who have marketed these medical devices on Romanian territory based on suspended and withdrawn certificates, stop using them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service using the contact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.
In addition to the previously mentioned falsified certificates, we hereby draw the attention of interested parties that manufacturer EQUIMEDICAL BV, the Netherlands also holds two other falsified certificates of conformity of the Management System with the requirements of ISO 13485:2003/NS-EN ISO 13485:2016 for the design, manufacture and wholesale activities of several types of medical devices, among which Oxidized regenerated cellulose. These certificates are: no. 277179-2019-AQ-IBE-NA-PS-Rev1.0 issued on 28 February 2019 and valid until 27 February 2024 and no. 277179-2019-AQ-IBE-NA-PS-Rev 2.0 issued on 21 April 2021 and valid until 20 April 2026 and were apparently issued by the same body, DNV GL NEMKO PRESAFE AS, Norway.