Kunshan Radiant Innovation Co L T D

FDA Filings

This page includes the latest FDA filings for Kunshan Radiant Innovation Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004026659
• FEI Number: 3005961978
• Name: KUNSHAN RADIANT INNOVATION CO., LTD.
• Owner & Operator: RADIANT INNOVATION, INC.
• Contact Address: 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK; HSINCHU TW-NOTA 300 TW
• US Agent:
  • ALAN P. SCHWARTZ
  • MDI CONSULTANTS, INC.
  • 516 4829001
  • 516 4820186
  • ALAN@MDICONSULTANTS.COM
• Importing Logistics Registration:
  • Importer: COMPONENT DESIGN NORTHWEST, INC. DBA CDN
  • Address: 2355 NW Vaughn St. ; Portland, OR 97210 UNITED STATES
  • Email Address: jan@CDNkitchen.com
• Importing Logistics Registration:
  • Importer: Metris Instruments east, llc
  • Address: 25 Long Meadow Place ; South Setauket, NY 11720 UNITED STATES
• Importing Logistics Registration:
  • Importer: THERMOWORKS INC.
  • Address: 741 E. UTAH VALLEY DR ; American Fork, UT 84003 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO. 20, TAIHONG ROAD KUN SHAN CITY; JIANGSU PROVINCE Jiangsu, 215300 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K162083 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	RII Multi-function Infrared Thermometer, Model TH52Z	2017-01-10
PMN K162083 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Multi-function Infrared Thermometer, Model THi0K,THi0KZ	2017-01-10
PMN K162083 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Multi-function Infrared Thermometer, Model TH520. TH520K	2017-01-10
PMN K162083 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Multi-function Infrared Thermometer, Model TH50Z, TH50ZK, TH500K	2017-01-10
PMN K162083 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Multi-function Infrared Thermometer, Model TH005K, TH007K	2017-01-10
FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-contact Forehead Thermometer,THMC2FE	2014-12-30
FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-contact Forehead Thermometer,MC-720	2014-12-30
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Tommee Tippee Digital No Touch Thermometer, THD2FE	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	ThermoWorks Wand, Model TW-5400,THD2FE	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Precise Position Forehead Thermometer, Model TH104	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-contact Forehead Thermometer,MC-720	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Infrared Forehead Thermometer, Model THD2FE	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Forehead Thermometer, Model THR0F	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Forehead Thermometer, Model THD2FAE	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Forehead Thermometer, Model IN176,THD2FE	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Clinical Thermometer, Model THi0F	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Clinical Thermometer, Model THD2FA/THD2FE	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Clinical Thermometer, Model THB0F	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Clinical Thermometer, Model TH36F	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Clinical Thermometer, Model TH30F	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Non-Contact Clinical Thermometer, Model TH01BF	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	FT90	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Easy Read Dual Mode Thermometer, Model TH095	2012-07-22
PMN K121428 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Easy Read Dual Mode Forehead Thermometer, Model TH091	2012-07-22
PMN K111637 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, electronic, clinical	2011-12-22
PMN K111637 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	THP79JU	2011-12-22
PMN K111637 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Infrared Ear Thermometer, Model THP59JU	2011-12-22
PMN K111637 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Infrared Ear Thermometer, Model THP59JB	2011-12-22
PMN K103097 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Infrared Ear Thermometer	2011-03-02
PMN K103097 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	IRT3020US-A	2011-03-02
PMN K102187 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, electronic, clinical	2011-03-02
PMN K102187 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	MC-521	2011-03-02
PMN K101253 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Various names and Models	2010-11-17
PMN K101253 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	INFRARED EAR THERMOMETER	2010-11-17
PMN K070976 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model TH01BN	2007-11-25
PMN K070976 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	FT55	2007-11-25
PMN K063185 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model TH5XY series	2007-11-25
PMN K051269 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model TH00XY series	2007-11-25
PMN K040377 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model THXXN series	2007-11-25
PMN K030324 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model TH1 series	2007-11-25
PMN K020504 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Tommee Tippee Digital Ear Thermometer, TH889SE	2007-11-25
PMN K020504 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Tommee Tippee Digital Ear Thermometer Hygiene Covers, PC840	2007-11-25
PMN K020504 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model TH88 series	2007-11-25
PMN K011059 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Thermometer, Model TH8 series	2007-11-25
PMN K011059 | FLL KUNSHAN RADIANT INNOVATION CO., LTD. [RADIANT INNOVATION, INC.]	Infrared Ear Thremometer Probe Cover, Model PC7200	2007-11-25

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092546803	Shanghai ,China (Mainland) -> Long Beach, California	TT DIGITAL EAR THERMOMETE 902519	375 PKG
2020082629730	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	INFRARED THERMOMETER	55 CTN
2020081232009	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	INFRARED THERMOMETER	29 CTN
2020081068966	Shanghai ,China (Mainland) -> Long Beach, California	INFRARED THERMOMETER	250 CTN
2020070419582	Shanghai ,China (Mainland) -> Seattle, Washington	INFRARED THERMOMETER	6 PKG
2019072335656	Shanghai ,China (Mainland) -> Long Beach, California	INFRARED THERMOMETER HS:90251990	9 CTN
2019061131930	Shanghai ,China (Mainland) -> Long Beach, California	INFRARED THERMOMETER 902519	62 CTN
2019061055222	Shanghai ,China (Mainland) -> Long Beach, California	INFRARED THERMOMETER 902519	62 CTN