BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    IRI MCM

    Reg #: 3002694097 · FEI: 3002694097 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Canon Medical Diagnostics Corporation Fuji Plant.
    Registration Number
    3002694097
    FEI Number
    3002694097
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600-1, MINAMI-ISHIKI,NAGAIZUMI-CHO
    City
    SUNTO-GUN Shizuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K162538

    Owner / Operator

    Firm Name
    Canon Medical Diagnostics Corporation
    Operator Number
    9031887
    Address
    8-10, 1 CHOME HARUMI, --
    City
    CHUO-KU
    State
    Tokyo
    Postal Code
    104-6004
    Country
    JP
    Correspondent
    Ken - Yasue

    US Agent

    Business Name
    Canon Medical Diagnostics USA, Inc.
    Contact Name
    Donald Postel
    Address
    630 Clyde Court
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US
    Email
    [email protected]
    Phone
    650 2102650

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT

    Proprietary Names

    IRI MCM IRI Calibrator (2-pack)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)