BEUDAMED
    MDR MDR QMS Amended

    006-00-01-MDR

    Manufacturer: Mt Ortho
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    01
    494
    Valid for 494 days
    Expiry: October 16, 2027

    Basic Information

    Number
    006-00-01-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 11, 2022
    Expiry Date
    October 16, 2027
    Revision
    01
    Manufacturer
    Mt Ortho

    Certificate Lifecycle

    November 11, 2022 October 16, 2027

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Custom Made Device

    Class III custom-made orthopaedic implantable devices as devices for vertebral surgery, devices for maxillofacial surgery and orthopedic devices in contact with central nervous system

    Quality Procedure Scope

    Device Group Class III

    Class III custom-made non-active orthopaedic implantable devices

    Preceding Certificates

    006-00-00-MDR Issued
    Issued: October 17, 2022 Expires: October 16, 2027

    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.