Among our protective mask range, the GVS Segre F3100 folded mask has received a new registration as a Class I Medical Device according to EU 2017/745; Medical Device Regulation.
The registration is now included in the GVS Class I Medical Device Declaration of Conformity.
Declaration of ConformitySegre F3100 falls into the highest EN149 protection class, FFP3, and now also conforms to EN14683:2019 as a Type IIR surgical mask.
CE CertificateThis means that the mask has a Particulate Filtration Efficiency > 99%, BFE (Bacterial Filtration Efficiency) > 98%; tested against synthetic blood penetration (Splash Resistance Pressure >16.0 kPa); Differential Pressure <60 pa/cm2; is non-cytotoxic and does not ignite.
Technical Data SheetFind more about F31000 Mask
![Two masks in one: our FFP3 Segre mask can now also be used as a medical device thanks to a new certification. ](https://static.gvs.com/articles/contents/images/202112200951-31b623dac3a76846/card_dottoressa_1.jpg)