BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    ASAHI MIRACLEbros 4.5 300cm

    Reg #: 3009121749 · FEI: 3009121749 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    36
    Establishment Types
    1
    Classifications
    2

    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
    K171933

    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
    Catheter, Percutaneous DQY
    Wire, Guide, Catheter DQX

    Proprietary Names

    ASAHI MIRACLEbros 4.5 300cm ASAHI CONFIANZA PRO 180cm ASAHI Gaia First ASAHI Corsair Pro, 150cm ASAHI Gaia Third 300cm Pre-shape ASAHI ULTIMATEbros 3 300cm J ASAHI ULTIMATEbros 3 180cm ASAHI MIRACLEbros 6 300cm ASAHI ULTIMATEbros 3 180cm J ASAHI CONFIANZA PRO 12 180cm ASAHI MIRACLEbros 6 180cm ASAHI MIRACLEbros 12 180cm ASAHI Gaia First 300cm Pre-shape ASAHI FIELDER XT 300cm ASAHI Gaia Third ASAHI Corsair Pro, 135cm ASAHI ULTIMATEbros 3 300cm ASAHI MIRACLEbros 3 300cm ASAHI Gaia Second Pre- shape ASAHI MIRACLEbros 12 300cm ASAHI FIELDER XT-R 300cm ASAHI FIELDER XT-R 190cm ASAHI Gaia Second 300cm Pre-shape ASAHI MIRACLEbros 4.5 180cm ASAHI Gaia Second ASAHI MIRACLEbros 3 180cm ASAHI FIELDER XT-A 190cm ASAHI Gaia Second 300cm ASAHI CONFIANZA PRO 300cm ASAHI Gaia Third 300cm ASAHI Gaia First Pre- shape ASAHI CONFIANZA PRO 12 300cm ASAHI FIELDER XT-A 300cm ASAHI FIELDER XT 190cm ASAHI Gaia Third Pre- shape ASAHI Gaia First 300cm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)