BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    RightTemp Ear thermometer and Probe Cover

    Reg #: 3016509757 · FEI: 3016509757 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FORTECHGRP CO., LTD.
    Registration Number
    3016509757
    FEI Number
    3016509757
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.62, Dingxing Rd., Guishan Dist.,
    City
    Taoyuan city
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K090031

    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

    Proprietary Names

    RightTemp Ear thermometer and Probe Cover V-Temp IR Ear thermometer and Probe Cover, Actherm IR Ear thermometer and Probe Cover

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)