BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ASSY,CABLE,DOCO TO ILLUMINATOR

    Reg #: 3017820152 · FEI: 3017820152 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DKSH Taiwan Ltd.
    Registration Number
    3017820152
    FEI Number
    3017820152
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 629, Sec 2, Meishi Rd.
    City
    Yangmei Dist. Taoyuan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K101077

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US
    Correspondent
    Mario Lowe

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ
    System, Surgical, Computer Controlled Instrument NAY
    System, X-Ray, Angiographic IZI

    Proprietary Names

    ASSY,CABLE,DOCO TO ILLUMINATOR DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR STARTER KIT,FF100 VISION DUCT,RIGHT,ILLUMINATOR,FIREFLY100 8.5 mm Endoscope, 30° BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000 12 mm Endoscope, 0° CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100 DUCT,LEFT,ILLUMINATOR,FIREFLY100 da Vinci Fluorescence Imaging Vision System ASSY,CABLE,CORE TO DOCO 8.5 mm Endoscope, 0° 12 mm Endoscope, 30° Camera Head Cable Fluorescence Imaging Camera Head and Cable Kit Fluorescence Imaging Illuminator

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device