BEUDAMED
    MDR MDR QMS Issued

    CR-03-1224-781-22

    Manufacturer: PulseOn Oy
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    01
    261
    Valid for 261 days
    Expiry: February 25, 2027

    Basic Information

    Number
    CR-03-1224-781-22
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 24, 2022
    Expiry Date
    February 25, 2027
    Validity Start
    February 25, 2022
    Revision
    01
    Manufacturer
    PulseOn Oy

    Certificate Lifecycle

    February 24, 2022 February 25, 2027

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    MDA 0203 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.