BEUDAMED
    IVDR IVDR QMS Supplemented

    IQMS/00003/0 v002

    Manufacturer: MacroArray Diagnostics
    Basic UDI-DIs
    0
    Scopes
    5
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    v002
    1197
    Valid for 1197 days
    Expiry: September 17, 2029

    Basic Information

    Number
    IQMS/00003/0 v002
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    September 18, 2024
    Expiry Date
    September 17, 2029
    Revision
    v002
    Manufacturer
    MacroArray Diagnostics

    Certificate Lifecycle

    September 18, 2024 September 17, 2029

    Scopes

    5 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class C

    W0201 IVP 3007

    Quality Procedure Scope

    Device Group Class C

    W0102 IVP 3007

    Quality Procedure Scope

    Device Class C

    Quality Procedure Scope

    Device Class C

    Quality Procedure Scope

    Device Class C

    Preceding Certificates

    IQMS/00003/0 v001 Issued
    Issued: September 18, 2024 Expires: September 17, 2029

    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.