BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    “POINT” Kinguide Agile Hybrid Navigation System

    Reg #: 3021976927 · FEI: 3021976927 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POINT ROBOTICS MEDTECH INC.
    Registration Number
    3021976927
    FEI Number
    3021976927
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7F., No. 219, Sec. 3, Beixin Rd.
    City
    Xindian Dist. New Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K241130

    Owner / Operator

    Firm Name
    Point Robotics MedTech Inc.
    Operator Number
    10084311
    Address
    5F, No.130, Sec. 2, Shengyi Rd., Hsinchu Science Park
    City
    Zhubei City
    State
    Hsinchu
    Postal Code
    30261
    Country
    TW
    Correspondent
    Wayne Kao

    US Agent

    Business Name
    Point Robotics Corp, USA
    Contact Name
    Wayne Kao
    Address
    530 Lytton Ave Suite 300 . Palo Alto Ca 94301 Us
    City
    Palo Alto
    State
    CA
    ZIP
    94301
    Country
    US
    Email
    [email protected]
    Phone
    626 6783360

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    “POINT” Kinguide Agile Hybrid Navigation System

    Establishment Types

    Manufacture Medical Device