KUNSHAN RADIANT INNOVATION CO., LTD.

FDA Device Registration & Listing · JIANGSU PROVINCE, CN · Registration 3004026659

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004026659
FEI Number
3005961978
Entity Name
KUNSHAN RADIANT INNOVATION CO., LTD.
City/State/Country
JIANGSU PROVINCE, CN
Establishment Address
NO. 20, TAIHONG ROAD, KUN SHAN CITY, JIANGSU PROVINCE 215300, CN
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
RADIANT INNOVATION, INC. (Owner Number: 9045429)
Owner / Operator Contact Address
1F,NO. 3,INDUSTRIAL E. 9TH RD, SCIENCE-BASED INDUSTRIAL PARK, HSINCHU, TW-NOTA 300, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2012-07-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2010-11-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-12-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-11-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-11-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-11-25
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-09-08
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2024-06-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-03-02
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-11-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2017-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

ALAN Schwartz Business: MDI CONSULTANTS, INC. Email: ALAN@MDICONSULTANTS.COM Phone: (516) 4829001

Related Public Records

Same Entity

RADIANT INNOVATION, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9710548 RADIANT INNOVATION INC. HSINCHU, TW

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004026659. Last updated year: 2026. Please use registration number 3004026659 when referencing this establishment in official correspondence.
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