23.03.2023
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: Equispon Sterile Haemostatic Absorbable Gelatin Sponges, manufactured by EQUIMEDICAL BV, the Netherlands, if they have come into possession of the falsified copy of the CE certificate of conformity no. 12493-2018-CE-IBE-NA-PS Rev. 1.0 and of the CE certificate of conformity no. 12492-2018-CE-IBE-NA-PS Rev. 1.0, which would have been issued by Notified Body DNV GL PRESAFE AS, Norway (2460) on 21 April 2021, valid until 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 Equispon Sterile Haemostatic Absorbable Gelatin Sponges, manufactured by EQUIMEDICAL BV, the Netherlands based on the 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 would hereby like to 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 EC certificate of conformity no. 12492-2018-CE-IBE-NA-PS and EC certificate of conformity no. 12493-2018-CE-IBE-NA-PS, both valid until 28 Mai 2023, were suspended by the issuing Notified Body (2460) on 28 May 2019 and recalled by the issuing Notified Body (2460) on 11 September 2019. If you have come into possession of such medical devices or are aware of distributors who sell on the Romanian territory these medical devices based on suspended and recalled 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.