BEUDAMED
    MDR MDR QMS Supplemented

    HZ 2042319-1

    Manufacturer: Huawei Device Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    1
    448
    Valid for 448 days
    Expiry: August 31, 2027

    Basic Information

    Number
    HZ 2042319-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 16, 2024
    Expiry Date
    August 31, 2027
    Revision
    1
    Manufacturer
    Huawei Device Co., Ltd.

    Certificate Lifecycle

    August 16, 2024 August 31, 2027

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    Z12050392 ELECTROCARDIOGRAPHS – MEDICAL DEVICE SOFTWARE

    Quality Procedure Scope

    Device Group Class IIa

    Z12030203 BLOOD PRESSURE MONITORING INSTRUMENTS Z12050404 BLOOD PRESSURE HOLTER RECORDERS

    Preceding Certificates

    HZ 2042319-1 Issued
    Issued: September 1, 2022 Expires: August 31, 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.