FDA Registration Active 🇨🇳 China

KUNSHAN RADIANT INNOVATION CO., LTD.

Reg #: 3004026659 · FEI: 3005961978 · Expires 2026
Products
2
Proprietary Names
62
Establishment Types
2
Classifications
2

Registration Details

Registration Name
KUNSHAN RADIANT INNOVATION CO., LTD.
Registration Number
3004026659
FEI Number
3005961978
Status
Active
Expiry Year
2026
Initial Importer
No
Address
NO. 20, TAIHONG ROAD, KUN SHAN CITY
City
JIANGSU PROVINCE
Country
CN

Regulatory Submissions

510(k) Number
K020504

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
Phone
516 4829001

Products

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

Proprietary Names

Non-Contact Clinical Thermometer, Model TH30F Non-Contact Clinical Thermometer, Model THi0F Non-Contact Clinical Thermometer, Model TH01BF Non-Contact Clinical Thermometer, Model TH36F Non-Contact Infrared Forehead Thermometer, Model THD2FA Tommee Tippee Digital No Touch Thermometer, THD2FE Easy Read Dual Mode Thermometer, Model TH095 Easy Read Dual Mode Forehead Thermometer, Model TH091 Non-Contact Forehead Thermometer, Model THR0F Thermoworks WAND Blue, Model THD2FE-B Non-Contact Forehead Thermometer, Model THD2FAE Precise Position Forehead Thermometer, Model TH104 ThermoWorks Wand, Model TW-5400,THD2FE Non-Contact Infrared Forehead Thermometer, Model THD2FE Non-Contact Forehead Thermometer, Model IN176,THD2FE Non-Contact Infrared Forehead Thermometer, Model THD2FEB Non-Contact Forehead Thermometer, Model ET720 Multi-function Medical/Surface Infrared Thermometer,52225-MED Non-Contact Clinical Thermometer, Model THB0F Non-Contact Forehead Thermometer, Model TH02F FT90 INFRARED EAR THERMOMETER Various names and Models Infrared Ear Thermometer, Model THW07N Infrared Ear Thermometer, Model THWB7N Thermometer, electronic, clinical THP79JU Infrared Ear Thermometer, Model THP59JB Infrared Ear Thermometer, Model THP59JU Infrared Ear Thermometer, Model THP79JB Infrared Ear Thermometer, Model THP89JB Infrared Ear Thermometer, Model THP59J Thermometer, Model TH88 series Tommee Tippee Digital Ear Thermometer Hygiene Covers, PC840 Tommee Tippee Digital Ear Thermometer, TH889SE Infrared Ear Thermometer, TH819SJE Thermometer, Model TH01BN Thermometer, Model TH8 series Infrared Ear Thermometer Probe Cover, Model PC7200 Infrared Ear Thermometer Probe Cover, Model PC 840 Infrared Ear Thermometer Probe Cover, Model PCL A40 Infrared Ear Thermometer Probe Cover, Model MDS9701 Thermometer, Model MDS9700 continuous measurement thermometer - ThermoWorks WAND Cinical; ThermoWorks WAND Mini Infrared Ear Thermometer, Model: THP86JE, THP86JEU, THR96JE, THR86JE, TH809J, MDS9700 Non-contact Forehead Thermometer, Model: THD2FE, TH48FE, TH09F Probe Cover: PC 7200, PC 840, MDSM3A7208058 Non-Contact Clinical Thermometer, Model THD2FE WAND Clinical Non-Contact, Digital Forehead Thermometer, Model TX-5710 Non-Contact Clinical Thermometer, Model TH09F WAND Mini Non-Contact, Digital Forehead Thermometer, Model TX-5700 Non-Contact Clinical Thermometer, Model TH48FE MC-521 Infrared Ear Thermometer, Model TH709L Thermometer, Model TH5XY series RII Multi-function Infrared Thermometer, Model TH52Z Multi-function Infrared Thermometer, Model TH50Z, TH50ZK, TH500K Multi-function Infrared Thermometer, Model TH520. TH520K Multi-function Infrared Thermometer, Model THi0K,THi0KZ Multi-function Infrared Thermometer, Model TH005K, TH007K Multi Function Infrared Thermometer, Model UT-801-FSA Thermometer, Model THXXN series

Establishment Types

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