BEUDAMED
    MDR MDR QMS Issued

    170781278

    Manufacturer: Huma Therapeutic Limited
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    632
    Valid for 632 days
    Expiry: March 1, 2028

    Basic Information

    Number
    170781278
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 2, 2023
    Expiry Date
    March 1, 2028
    Manufacturer
    Huma Therapeutic Limited

    Certificate Lifecycle

    March 2, 2023 March 1, 2028

    Scopes

    2 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Group Class IIb

    MDA 0315 – Software

    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.