BEUDAMED
    MDR MDR QMS Issued

    1000164455

    Manufacturer: Huma Therapeutics Limited
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    04
    631
    Valid for 631 days
    Expiry: March 1, 2028

    Basic Information

    Number
    1000164455
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 1, 2024
    Expiry Date
    March 1, 2028
    Revision
    04
    Manufacturer
    Huma Therapeutics Limited

    Certificate Lifecycle

    February 1, 2024 March 1, 2028

    Scopes

    3 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    MDA 0315 – Software

    Quality Procedure Scope

    Device Class IIb

    Quality Procedure Scope

    Device Class IIb

    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.