BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Dialysis Calibrator

    Reg #: 3004378326 · FEI: 3004378326 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Tokyo Boeki Medisys Inc.
    Registration Number
    3004378326
    FEI Number
    3004378326
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-14-21 Higashitoyoda
    City
    Hino Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K040958

    Owner / Operator

    Firm Name
    Tokyo Boeki Medisys, Inc.
    Operator Number
    9060135
    Address
    1-14-21, Higashitoyoda
    City
    Hino, Tokyo
    State
    JP-NOTA
    Postal Code
    191-0052
    Country
    JP
    Correspondent
    Hiroshi Miyazato

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Electrode, Ion Specific, Potassium CEM

    Proprietary Names

    Dialysis Calibrator Urine Calibrator Set Calibrator 1 Calibrator 2 K (Potassium) Electrode Cl (Chloride) Electrode Na (Sodium) Electrode Calibrator Set A, B

    Establishment Types

    Manufacture Medical Device