BEUDAMED
    MDR MDR QMS Issued

    HZ 2100418-1

    Manufacturer: GaleMed Corporation
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    2
    700
    Valid for 700 days
    Expiry: May 8, 2028

    Basic Information

    Number
    HZ 2100418-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 13, 2023
    Expiry Date
    May 8, 2028
    Revision
    2
    Manufacturer
    GaleMed Corporation

    Certificate Lifecycle

    November 13, 2023 May 8, 2028

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Measuring Function

    Z121501 - SPIROMETRY INSTRUMENTS

    Quality Procedure Scope

    Device Group Class IIa

    R020101 - STANDARD BREATHING CIRCUITS R020102 - COAXIAL BREATHING CIRCUITS R020104 - CPAP AND NIV BREATHING CIRCUITS R020106 - IPPB CIRCUITS R030101 - VENTILATION MASKS R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS R030103 - AEROSOL THERAPY MASKS AND SYSTEMS R030202 - MANUALLY OPERATED VENTILATION BALLOONS R040102 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS R060202 - OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS

    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.