BEUDAMED
    MDR MDR QMS Supplemented

    016-00-01-MDR

    Manufacturer: EVOLUTIS
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    01
    666
    Valid for 666 days
    Expiry: April 5, 2028

    Basic Information

    Number
    016-00-01-MDR
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 21, 2024
    Expiry Date
    April 5, 2028
    Validity Start
    November 22, 2024
    Revision
    01
    Manufacturer
    EVOLUTIS

    Certificate Lifecycle

    November 21, 2024 April 5, 2028

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class III

    Non-active osteo- and orthopaedic implants

    Quality Procedure Scope

    Device Class III

    Quality Procedure Scope

    Device Class III

    Preceding Certificates

    016-00-00-MDR Issued
    Issued: April 6, 2023 Expires: April 5, 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.