BEUDAMED
    MDR MDR QMS Supplemented

    HZ 2102042-1

    Manufacturer: OMRON Healthcare Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    1
    Revision
    Rev.8
    28
    Expires in 28 days
    Expiry: July 6, 2026

    Basic Information

    Number
    HZ 2102042-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 17, 2024
    Expiry Date
    July 6, 2026
    Revision
    Rev.8
    Manufacturer
    OMRON Healthcare Co., Ltd.

    Certificate Lifecycle

    December 17, 2024 July 6, 2026

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    V030101 – THERMOMETERS Z120302 – VITAL SIGNS MONITORING INSTRUMENTS R060101 – COLD NEBULISATION SYSTEMS N010201 – TENS SYSTEM ELECTRODES Z120628 – NEUROMUSCULAR STIMULATION EQUIPMENT Z121590 – VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS Z120503 – ELECTROCARDIOGRAPHS Z12050392 – ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE R030103 – AEROSOL THERAPY MASKS AND SYSTEMS

    Quality Procedure Scope

    Device Group Class I Measuring Function

    Z12099001 – BODY IMPEDANCE ANALYSERS The scope of certification is limited to the aspects relating to the conformity of the devices with the metrological requirements

    Preceding Certificates

    HZ 2102042-1 Issued
    Issued: September 9, 2024 Expires: July 6, 2026

    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.