BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Eiken Chemical Co., Ltd. Nasu Plant

    Reg #: 3007114058 · FEI: 3007114058 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Eiken Chemical Co., Ltd. Nasu Plant
    Registration Number
    3007114058
    FEI Number
    3007114058
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1381-3, Shimoishigami
    City
    Ohtawara-shi Tochigi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K041408

    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
    Automated Occult Blood Analyzer OOX

    Proprietary Names

    OC-Auto Micro 80 FOB Test OC-Auto Sensor io iFOB Test OC-Sensor DIANA iFOB Test

    Establishment Types

    Manufacture Medical Device