BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FMD Co., Ltd. Okinawa Factory

    Reg #: 3014977413 · FEI: 3014977413 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FMD Co., Ltd. Okinawa Factory
    Registration Number
    3014977413
    FEI Number
    3014977413
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5194-15 Katsuren Haebaru
    City
    Uruma Okinawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K212268

    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

    JUDO 3 Guidewire JUDO 1 Guidewire JUDO 6 Guidewire Hornet™ Guidewire Hornet™ 10 Guidewire Hornet™ 14 Guidewire FMD Peripheral Guidewire F-14 Light FMD Peripheral Guidewire F-18 Flex FMD Peripheral Guidewire F-14 Tapered3 FMD Peripheral Guidewire F-14 Tapered15 FMD Peripheral Guidewire F-18 Hard15 FMD Peripheral Guidewire F-14 EXT FMD Peripheral Guidewire F-14 Tapered30 FMD Peripheral Guidewire F-18 Floppy FMD Peripheral Guidewire F-14 Flex FMD Peripheral Guidewire F-14 Gentle Marvel™ Guidewire Fighter™ Guidewire Stretch Extension Wire Samurai™ RC Guidewire Samurai™ Guidewire FMD Peripheral Guide Wire F-18 Flex 400

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device