BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Ambu® aScope™ Colon

    Reg #: 3012843412 · FEI: 3012843412 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BRITEMED TECHNOLOGY INC.
    Registration Number
    3012843412
    FEI Number
    3012843412
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3F., No. 306,306-3, 13F., No. 306,306-3, Sec. 1, Datong Rd., Xizhi Dist.,
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K230332

    Owner / Operator

    Firm Name
    BriteMED Technology Inc.
    Operator Number
    10062321
    Address
    3F., No. 306,306-3, 13F., No. 306,306-3, Sec. 1, Datong Rd., Xizhi Dist.,
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    221
    Country
    TW
    Correspondent
    Janet Lu

    US Agent

    Business Name
    IEI Technology USA Corporation
    Contact Name
    Shawn Tsai
    Address
    138 university pkwy, pomona, CA 91768
    City
    Pomona
    State
    CA
    ZIP
    91768
    Country
    US
    Email
    [email protected]
    Phone
    909 5952819 ext. 133

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET

    Proprietary Names

    Ambu® aScope™ Colon Ambu® aBox™ 2

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)