BEUDAMED
    IVDR IVDR QMS Amended

    HX 2074650-1

    Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    .1
    1099
    Valid for 1099 days
    Expiry: June 12, 2029

    Basic Information

    Number
    HX 2074650-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    December 27, 2024
    Expiry Date
    June 12, 2029
    Revision
    .1
    Manufacturer
    Assure Tech. (Hangzhou) Co., Ltd.

    Certificate Lifecycle

    December 27, 2024 June 12, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class B

    INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents. W01050901 - BACTERIOLOGY - RT & POC

    Preceding Certificates

    HX 2074650-1 Amended
    Issued: December 27, 2024 Expires: June 12, 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.