BEUDAMED
    FDA Registration Active 🇨🇳 China

    Thermometer, Model TH8 series

    Reg #: 3004026659 · FEI: 3005961978 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K011059

    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

    Thermometer, Model TH8 series Infrared Ear Thermometer Probe Cover, Model PC7200 Infrared Ear Thermometer Probe Cover, Model PCL A40 Infrared Ear Thermometer Probe Cover, Model PC 840 Infrared Ear Thermometer Probe Cover, Model MDS9701 Thermometer, Model MDS9700

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)