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            Segre F31000 has received a new registration as medical device

            A doctor that wear two masks, one above the other.

            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 Conformity

            Segre F3100 falls into the highest EN149 protection class, FFP3, and now also conforms to EN14683:2019 as a Type IIR surgical mask. 

            CE Certificate

            This 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 Sheet

            Find 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.&nbsp;
            Two masks in one: our FFP3 Segre mask can now also be used as a medical device thanks to a new certification.