BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Sodium Electrode

    Reg #: 1000256526 · FEI: 1000256526 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    HORIBA LTD.
    Registration Number
    1000256526
    FEI Number
    1000256526
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 MIYANOHIGASHI, KISSHOIN,, MINAMI-KU
    City
    KYOTO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K183375

    Owner / Operator

    Firm Name
    HORIBA LTD.
    Operator Number
    9052537
    Address
    2 MIYANOHIGASHI, KISSHOIN,, MINAMI-KU
    City
    KYOTO
    State
    JP-26
    Postal Code
    601-8510
    Country
    JP
    Correspondent
    JUNYA - OKETANI

    US Agent

    Business Name
    HORIBA Instruments Incorporated
    Contact Name
    Will Cripps
    Address
    5449 Research Drive, Canton, MI 48188
    City
    Canton
    State
    MI
    ZIP
    48188
    Country
    US
    Email
    [email protected]
    Phone
    800 4459853

    Products

    Device Name Product Code
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hexokinase, Glucose CFR
    Electrode, Ion-Specific, Chloride CGZ

    Proprietary Names

    Sodium Electrode Potassium Electrode Chloride Electrode YUMIZEN C1200

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility