BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Alinity i Insulin Calibrators

    Reg #: 3003871639 · FEI: 3003871639 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    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

    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
    Calibrator, Secondary JIT

    Proprietary Names

    Alinity i Insulin Calibrators Alinity c Rheumatoid Factor Calibrator Kit ARCHITECT Insulin Calibrators ARCHITECT Insulin Controls

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device