BEUDAMED
    MDR MDR QMS Withdrawn

    ITH 2373551 1

    Manufacturer: Advanced Osteotomy Tools - AOT AG
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    3
    Characteristics
    1
    Revision
    1.0
    Withdrawn
    Expiry: October 18, 2027

    Basic Information

    Number
    ITH 2373551 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 28, 2023
    Expiry Date
    October 18, 2027
    Revision
    1.0
    Decision Date
    September 7, 2023
    Manufacturer
    Advanced Osteotomy Tools - AOT AG

    Certificate Lifecycle

    February 28, 2023 October 18, 2027

    Device Characteristics

    Sterile Intended Medical Purpose

    Scopes

    2 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Other active non-implantable surgical devices

    Quality Procedure Scope

    Device Group Class IIa Class I Sterile

    Non-active non-implantable instruments

    Preceding Certificates

    ITH 2373551 1 Issued
    Issued: February 28, 2023 Expires: October 18, 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.