BEUDAMED
    MDR MDR QMS Issued

    ITH 1343191 1

    Manufacturer: CARDIOLINE
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1.0
    1230
    Valid for 1230 days
    Expiry: October 20, 2029

    Basic Information

    Number
    ITH 1343191 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 21, 2024
    Expiry Date
    October 20, 2029
    Revision
    1.0
    Manufacturer
    CARDIOLINE

    Certificate Lifecycle

    October 21, 2024 October 20, 2029

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Software

    Quality Procedure Scope

    Device Group Class IIa

    Dispositivi non impiantabili attivi per il monitoraggio dei parametri fisiologici vitali / Active non-implantable devices for monitoring of vital physiological parameters

    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.