BEUDAMED
    MDR MDR QMS Issued

    HZ 2095583-1

    Manufacturer: Andon Health Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    1219
    Valid for 1219 days
    Expiry: October 9, 2029

    Basic Information

    Number
    HZ 2095583-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 10, 2024
    Expiry Date
    October 9, 2029
    Manufacturer
    Andon Health Co., Ltd.

    Certificate Lifecycle

    October 10, 2024 October 9, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class IIa

    Z120302 - VITAL SIGNS MONITORING INSTRUMENTS Z120628 - NEUROMUSCULAR STIMULATION EQUIPMENT V030101 - THERMOMETERS Z120306 - VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...)

    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.