BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Liposorber LA-15 system

    Reg #: 9614654 · FEI: 3002808904 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Kaneka Corporation Osaka Plant
    Registration Number
    9614654
    FEI Number
    3002808904
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-1-1, Torikai-nishi,
    City
    Settsu-shi Osaka
    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

    US Agent

    Business Name
    Kaneka Medical America LLC
    Contact Name
    Audra bogucki
    Address
    623 FIFTH AVE.,
    City
    NEW YORK
    State
    NY
    ZIP
    10022
    Country
    US
    Email
    [email protected]
    Phone
    917 6289870

    Products

    Device Name Product Code
    Lipoprotein, Low Density, Removal MMY

    Proprietary Names

    Liposorber LA-15 system

    Establishment Types

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