BEUDAMED
    MDR MDR QMS Issued

    IT326369

    Manufacturer: Biotechmed S.r.l.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    862
    Valid for 862 days
    Expiry: October 17, 2028

    Basic Information

    Number
    IT326369
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 18, 2023
    Expiry Date
    October 17, 2028
    Revision
    1
    Manufacturer
    Biotechmed S.r.l.

    Certificate Lifecycle

    October 18, 2023 October 17, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    MDA 0315 - Software - Strumentazione varia per supporto e monitoraggio dei parametri vitali - Dispositivi medici software

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.