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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. 

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