BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MyeLyte Touch

    Reg #: 3012057020 · FEI: 3012057020 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FANDF CO., LTD. MEDICAL DEVICE DEPARTMENT
    Registration Number
    3012057020
    FEI Number
    3012057020
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2969-2 Ishikawa-machi
    City
    Hachioji-shi Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K103531

    Owner / Operator

    Firm Name
    FandF Co., Ltd. Medical Device Department
    Operator Number
    10082420
    Address
    2969-2 Ishikawa-machi,
    City
    Hachioji-shi,
    State
    Tokyo
    Postal Code
    192-0032
    Country
    JP
    Correspondent
    Jun Matsubara

    US Agent

    Business Name
    GLOBIZZ CORPORATION
    Contact Name
    TAKAHIRO HARUYAMA
    Address
    970 W190th St, Suite 200
    City
    Torrance
    State
    CA
    ZIP
    90502
    Country
    US
    Email
    [email protected]
    Phone
    310 5383860

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    MyeLyte Touch IMMTOX 270 DZ-Lite c270 BIOLIS 30i

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)