BEUDAMED
    MDR MDR QMS Issued

    061-00-00-MDR

    Manufacturer: GPI S.P.A.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    1231
    Valid for 1231 days
    Expiry: October 22, 2029

    Basic Information

    Number
    061-00-00-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 23, 2024
    Expiry Date
    October 22, 2029
    Revision
    00
    Manufacturer
    GPI S.P.A.

    Certificate Lifecycle

    October 23, 2024 October 22, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Custom Made Device

    Class III custom-made orthopaedic implantable devices as temporomandibular joint reconstruction prosthesis, ankle joint reconstruction prosthesis, osteosynthesis prosthesis and cranial reconstruction prosthesis

    Quality Procedure Scope

    Device Group Class III

    Class III custom-made implantable devices

    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.