BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    FORTECHGRP CO., LTD.

    Reg #: 3016509757 · FEI: 3016509757 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    FORTECHGRP CO., LTD.
    Registration Number
    3016509757
    FEI Number
    3016509757
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.62, Dingxing Rd., Guishan Dist.,
    City
    Taoyuan city
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K070028

    Owner / Operator

    Firm Name
    FORTECHGRP CO., LTD.
    Operator Number
    10059155
    Address
    No.62, Dingxing Rd., Guishan Dist.,
    City
    Taoyuan city
    State
    TW-TAO
    Postal Code
    33345
    Country
    TW
    Correspondent
    Minghsien Lu

    US Agent

    Business Name
    Dynasty Medical Consulting Inc.
    Contact Name
    Linda Chen
    Address
    302 Round Lake Dr
    City
    Rosenberg
    State
    TX
    ZIP
    77469
    Country
    US
    Email
    [email protected]
    Phone
    832 3809688

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Clinical Electronic Thermometer SDV

    Proprietary Names

    V-Temp IR Ear thermometer and Probe Cover, Actherm IR Ear thermometer and Probe Cover RightTemp Ear thermometer and Probe Cover ForeHealth digital clinical thermometer Fore Health Forehead and Ear Infrared Thermometer ACT8000-F Fore Health Smart Ear Thermometer ACT8000-TB,ACT8000-TG Fore Health Smart Thermometer GAL05Ex-XX/BC MABIS - 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETER FAHRENHEIT 9 SECOND DIGITAL THERMOMETER FAHRENHEIT 9 SEC FLEX TIP DIG THERMOM FAHRENHEIT (VERTICAL PACKAGE)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device