BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    FIELDER FC

    Reg #: 3003780911 · FEI: 3003780911 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ASAHI INTECC (THAILAND) CO., LTD.
    Registration Number
    3003780911
    FEI Number
    3003780911
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    158/1 Moo 5, Bangkadi Idustrial Park, TIWANON ROAD, TAMBOL BANGKADI,
    City
    Amphur Muang Pathumthani Pathum Thani
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K163426

    Owner / Operator

    Firm Name
    ASAHI INTECC CO., LTD.
    Operator Number
    9051916
    Address
    3-100 Akatsuki-cho, --
    City
    Seto
    State
    Aichi
    Postal Code
    489-0071
    Country
    JP

    US Agent

    Business Name
    ASAHI INTECC USA, INC.
    Contact Name
    Yoshi Terai
    Address
    3002 Dow Ave Suite 212
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    949 7568636 ext. 501

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Guide, Wire, Catheter, Neurovasculature MOF

    Proprietary Names

    FIELDER FC Astato 30 PROWATER Halberd18 ASAHI Gaia PV18 Regalia XS 1 ASAHI SION MIRACLEBROS 3 Astato XS40 ASAHI Gladius18 Treasure Floppy ASAHI Gaia Third FIELDER XT-A ASAHI Gaia Second FIELDER XT-R MIRACLEBROS 12 PROWATERflex Treasure 12 MIRACLEBROS 6 Astato XS 20 CONFIANZA PRO GRAND SLAM EXTENSION SOFT FIELDER CONFIANZA PRO 12 ASAHI SION blue ASAHI Gaia First ULTIMATEbros 3 FIELDER XT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)