BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Supercath5

    Reg #: 3003184529 · FEI: 3003184529 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIKIT CO., LTD.
    Registration Number
    3003184529
    FEI Number
    3003184529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-13-2 YUSHIMA
    City
    BUNKYO KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K140419

    Owner / Operator

    Firm Name
    TOGO MEDIKIT CO., LTD.
    Operator Number
    8030371
    Address
    17148-6 AZA KAMEKAWA, OAZA HICHIYA
    City
    HYUGA CITY
    State
    Miyazaki
    Postal Code
    883-0062
    Country
    JP
    Correspondent
    TAKASHI - NAKAJIMA

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    Supercath5

    Establishment Types

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