BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HORIBA LTD.

    Reg #: 1000256526 · FEI: 1000256526 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    HORIBA LTD.
    Registration Number
    1000256526
    FEI Number
    1000256526
    Status
    Active
    Expiry Year
    2026
    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
    Hexokinase, Glucose CFR
    Electrode, Ion Specific, Potassium CEM
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    General Purpose Reagent PPM
    Calibrator, Multi-Analyte Mixture JIX
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Electrode, Ion Selective (Non-Specified) JJP

    Proprietary Names

    Sodium Electrode Potassium Electrode YUMIZEN C1200 Chloride Electrode Reagent Probe Wash 2 ISE Detergent Solution Reagent Probe Wash K Reagent Probe Wash 1 Cuvette Wash Solution 7 Cuvette Conditioner EX Lamp Coolant C ISE Buffer (IS) Reagent Probe Wash S I.S.E.MODULE ISE URINE STANDARD SET Internal Standard ISE SERUM STANDARD SET NA Reference Electrode

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)