BEUDAMED
    FDA Registration Active 🇨🇳 China

    OC-Light S FIT

    Reg #: 3007114066 · FEI: 3007114066 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Eiken China Co., Ltd.
    Registration Number
    3007114066
    FEI Number
    3007114066
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1058 Ha Lei Road, ZhangJiang Hi-Tech Park
    City
    Pudong new state Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K143325

    Owner / Operator

    Firm Name
    EIKEN CHEMICAL CO., LTD.
    Operator Number
    8031541
    Address
    4-19-9, Taito, --
    City
    Taito-ku
    State
    Tokyo
    Postal Code
    110-8408
    Country
    JP
    Correspondent
    Tadashi - Yasuda

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Reagent, Occult Blood KHE

    Proprietary Names

    OC-Light S FIT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)