BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SION blue PLUS

    Reg #: 3003775027 · FEI: 3003775027 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ASAHI INTECC CO., LTD.
    Registration Number
    3003775027
    FEI Number
    3003775027
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-100 AKATSUKI-CHO
    City
    SETO Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K243733

    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 7478636 ext. 501

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    SION blue PLUS

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device