BEUDAMED
    FDA Registration Active 🇨🇳 China

    FT90

    Reg #: 3004026659 · FEI: 3005961978 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KUNSHAN RADIANT INNOVATION CO., LTD.
    Registration Number
    3004026659
    FEI Number
    3005961978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 20, TAIHONG ROAD, KUN SHAN CITY
    City
    JIANGSU PROVINCE
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K121428

    Owner / Operator

    Firm Name
    RADIANT INNOVATION, INC.
    Operator Number
    9045429
    Address
    1F,NO. 3,INDUSTRIAL E. 9TH RD, SCIENCE-BASED INDUSTRIAL PARK
    City
    HSINCHU
    State
    TW-NOTA
    Postal Code
    300
    Country
    TW

    US Agent

    Business Name
    MDI CONSULTANTS, INC.
    Contact Name
    ALAN Schwartz
    Address
    55 NORTHERN BLVD., SUITE 200
    City
    GREAT NECK
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    FT90 Non-Contact Clinical Thermometer, Model TH01BF Non-Contact Clinical Thermometer, Model THi0F Non-Contact Infrared Forehead Thermometer, Model THD2FA Non-Contact Clinical Thermometer, Model TH36F Tommee Tippee Digital No Touch Thermometer, THD2FE Easy Read Dual Mode Forehead Thermometer, Model TH091 Easy Read Dual Mode Thermometer, Model TH095 Non-Contact Forehead Thermometer, Model THD2FAE Thermoworks WAND Blue, Model THD2FE-B Precise Position Forehead Thermometer, Model TH104 Non-Contact Forehead Thermometer, Model THR0F ThermoWorks Wand, Model TW-5400,THD2FE Non-Contact Infrared Forehead Thermometer, Model THD2FE Non-Contact Forehead Thermometer, Model IN176,THD2FE Multi-function Medical/Surface Infrared Thermometer,52225-MED Non-Contact Infrared Forehead Thermometer, Model THD2FEB Non-Contact Forehead Thermometer, Model ET720 Non-Contact Clinical Thermometer, Model TH30F Non-Contact Clinical Thermometer, Model THB0F Non-Contact Forehead Thermometer, Model TH02F

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)