BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    ASAHI Fielder XT-R 300cm

    Reg #: 3009121749 · FEI: 3009121749 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASAHI INTECC HANOI CO., LTD.
    Registration Number
    3009121749
    FEI Number
    3009121749
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    G03 Thang Long Industrial Park, Dong Anh District
    City
    Hanoi Ha Noi
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K153106

    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

    Proprietary Names

    ASAHI Fielder XT-R 300cm ASAHI Fielder XT-A 300cm ASAHI Fielder XT-R ASAHI Fielder XT-A

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)