BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OTSUKA ELECTRONICS CO., LTD.

    Reg #: 3005622096 · FEI: 3005622096 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    OTSUKA ELECTRONICS CO., LTD.
    Registration Number
    3005622096
    FEI Number
    3005622096
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-10, Sasagaoka, Minakuchi-cho
    City
    Koka-city Shiga
    Country
    JP

    Owner / Operator

    Firm Name
    Otsuka Electronics Co.,Ltd
    Operator Number
    10095518
    Address
    1-10, Sasagaoka, Minakuchi-cho
    City
    Koka-shi
    State
    Shiga
    Postal Code
    528-0061
    Country
    JP
    Correspondent
    Toshiyuki Mori

    US Agent

    Business Name
    FUJIREBIO DIAGNOSTICS, INC.
    Contact Name
    Greg Dickson
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    610 2403888

    Products

    Device Name Product Code
    Calibrator, Secondary JIT
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Lumipulse G1200 Instrument

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)