BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    JEOL LTD.

    Reg #: 3003637681 · FEI: 3003637681 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    JEOL LTD.
    Registration Number
    3003637681
    FEI Number
    3003637681
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-11-1 Inadaira
    City
    Musashimurayama Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K990346

    Owner / Operator

    Firm Name
    JEOL LTD.
    Operator Number
    9051046
    Address
    2-11-1 Inadaira, --
    City
    Musashimrayama
    State
    Tokyo
    Postal Code
    208-0023
    Country
    JP
    Correspondent
    Takeshi - Kaneko

    Products

    Device Name Product Code
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Potassium CEM
    General Purpose Reagent PPM
    Electrode, Ion Selective (Non-Specified) JJP
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    Sodium Electrode Chloride Electrode Potassium Electrode Reagent Probe Wash K Cuvette Conditioner EX Reagent Probe Wash 1 ISE Buffer (IS) Reagent Probe Wash S Cuvette Wash Solution 7 Reagent Probe Wash 2 Lamp Coolant C ISE Detergent Solution Cuvette Wash Solution 3 BM Test BATH FLUID 50 Cuvette Conditioner 3 Reference Electrode Internal Standard ISE SERUM STANDARD SET NA ISE URINE STANDARD SET

    Establishment Types

    Manufacture Medical Device