BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    EIKEN CHEMICAL CO., LTD. NOGI PLANT

    Reg #: 3005610352 · FEI: 3002806884 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    EIKEN CHEMICAL CO., LTD. NOGI PLANT
    Registration Number
    3005610352
    FEI Number
    3002806884
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    143 NOGI, NOGI-MACHI,
    City
    SHIMOTSUGA-GUN Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K143325

    Owner / Operator

    Firm Name
    EIKEN CHEMICAL CO., LTD.
    Operator Number
    8031541
    Address
    4-6 Kanda Surugadai, --
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    101-0062
    Country
    JP
    Correspondent
    Tadashi - Yasuda

    US Agent

    Business Name
    Jataki Company LLC
    Contact Name
    Derek Wessman
    Address
    3300 N Triumph Blvd Suite 100
    City
    Lehi
    State
    UT
    ZIP
    84043
    Country
    US
    Email
    [email protected]
    Phone
    801 6569278

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE
    Automated Occult Blood Analyzer OOX

    Proprietary Names

    OC-Light S FIT OC-Auto Micro 80 FOB Test OC-Sensor DIANA iFOB Test OC-Auto Sensor io iFOB Test

    Establishment Types

    Manufacture Medical Device