BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    BIOLIS 30i

    Reg #: 3004378326 · FEI: 3004378326 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    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
    K103531

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hexokinase, Glucose CFR

    Proprietary Names

    BIOLIS 30i IMMTOX 270 MyeLyte Touch DZ-Lite c270

    Establishment Types

    Manufacture Medical Device