BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    EDG v4

    Reg #: 3009761573 · FEI: 3009761573 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    KANEKA MEDIX CORPORATION KANAGAWA PLANT
    Registration Number
    3009761573
    FEI Number
    3009761573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    225-1 Aza Deguchi, Yamakita, Yamakita-machi
    City
    Ashigara-Kami-gun Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K210638

    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
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG

    Proprietary Names

    EDG v4 i-ED COIL

    Establishment Types

    Manufacture Medical Device