BEUDAMED
    MDR MDR QMS Supplemented

    CR-03-1154-812-23

    Manufacturer: PaloDEx Group Oy
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    03
    637
    Valid for 637 days
    Expiry: March 6, 2028

    Basic Information

    Number
    CR-03-1154-812-23
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 17, 2024
    Expiry Date
    March 6, 2028
    Revision
    03
    Manufacturer
    PaloDEx Group Oy

    Certificate Lifecycle

    May 17, 2024 March 6, 2028

    Scopes

    4 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    MDA 0201 Active non-implantable imaging devices utilising ionizing radiation

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    Preceding Certificates

    CR-03-1154-812-23 Supplemented
    Issued: March 10, 2023 Expires: March 6, 2028

    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.