BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FERRITIN, ANTIGEN, ANTISERUM, CONTROLCalibrator, secondary

    Reg #: 3003871639 · FEI: 3003871639 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DENKA CO., LTD.
    Registration Number
    3003871639
    FEI Number
    3003871639
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1359-1, KAGAMIDA, KIGOSHI
    City
    GOSEN-SHI Niigata
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K050944

    Owner / Operator

    Firm Name
    DENKA CO., LTD.
    Operator Number
    9053049
    Address
    1359-1, KAGAMIDA, KIGOSHI
    City
    GOSEN-SHI
    State
    Niigata
    Postal Code
    959-1695
    Country
    JP

    Products

    Device Name Product Code
    Ferritin, Antigen, Antiserum, Control DBF
    Calibrator, Secondary JIT

    Proprietary Names

    FERRITIN, ANTIGEN, ANTISERUM, CONTROLCalibrator, secondary

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)