BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Complement Control

    Reg #: 3003419906 · FEI: 3003419906 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)
    Registration Number
    3003419906
    FEI Number
    3003419906
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6-1 Takata-cho
    City
    Amagasaki-shi Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K960874

    Owner / Operator

    Firm Name
    FUJIFILM Wako Pure Chemical Corporation
    Operator Number
    8030234
    Address
    1-2 Doshomachi 3-Chome
    City
    Chuo-Ku
    State
    Osaka
    Postal Code
    540-8605
    Country
    JP

    US Agent

    Business Name
    FUJIFILM Healthcare Americas Corporation
    Contact Name
    Randy Vader
    Address
    81 Hartwell Ave Ste 300
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US
    Email
    [email protected]
    Phone
    360 3566821

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Complement Control

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility