BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Fighter™ Guidewire

    Reg #: 3014977413 · FEI: 3014977413 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FMD Co., Ltd. Okinawa Factory
    Registration Number
    3014977413
    FEI Number
    3014977413
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5194-15 Katsuren Haebaru
    City
    Uruma Okinawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K151840

    Owner / Operator

    Firm Name
    FMD Co., Ltd.
    Operator Number
    10052039
    Address
    Sasazuka Daiichi Bldg. 8F, 1-57-7 Sasazuka, Shibuya-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    151-0073
    Country
    JP
    Correspondent
    Mayumi Ito

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Fighter™ Guidewire Marvel™ Guidewire Samurai™ Guidewire Stretch Extension Wire Samurai™ RC Guidewire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)