BEUDAMED
    MDR MDR QMS Issued

    HZ 2068488-1

    Manufacturer: Changsha Sinocare Inc.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    1
    842
    Valid for 842 days
    Expiry: September 27, 2028

    Basic Information

    Number
    HZ 2068488-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 8, 2023
    Expiry Date
    September 27, 2028
    Revision
    1
    Manufacturer
    Changsha Sinocare Inc.

    Certificate Lifecycle

    December 8, 2023 September 27, 2028

    Device Characteristics

    Sterile

    Scopes

    Quality Procedure Scope

    Device Group Class IIb

    Z120401- GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS BLOOD SUGAR MONITORING SYSTEMS - Continuous Glucose Monitoring System GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE - Continuous Glucose Monitoring System 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.