BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KANEKA CORPORATION TOMATOH PLANT

    Reg #: 3031408734 · FEI: 3031408734 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    KANEKA CORPORATION TOMATOH PLANT
    Registration Number
    3031408734
    FEI Number
    3031408734
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6-253, Aza Kashiwabara
    City
    Tomakomai-city Hokkaido
    Country
    JP

    Regulatory Submissions

    PMA Number
    P910018

    Owner / Operator

    Firm Name
    KANEKA CORP.
    Operator Number
    9005249
    Address
    2-3-18, Nakanoshima, Kita-ku
    City
    Osaka
    State
    JP-27
    Postal Code
    530-8288
    Country
    JP
    Correspondent
    Takeaki - Miyata

    Products

    Device Name Product Code
    Lipoprotein, Low Density, Removal MMY
    Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients PBN

    Proprietary Names

    Liposorber LA-15 system Liposorber LA-15 System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device