Data / Medical devices / China / Kunshan Radiant Innovation Co., Ltd.
Kunshan Radiant Innovation Co., Ltd.: FDA-registered device maker in Jiangsu Province, China, 2 510(k) clearances
Kunshan Radiant Innovation Co., Ltd. is registered with the FDA (registration 3004026659) in Jiangsu Province, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 9, 2017. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3004026659
- FEI number
- 3005961978
- Address
- No. 20, Taihong Road Kun Shan City, Jiangsu Province, China, 215300
- Owner or operator
- RADIANT INNOVATION, INC. (9045429)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 25, 2007
- Registered through
- 2027
- Brand names listed
- Easy Read Dual Mode Forehead Thermometer, Model TH091, Easy Read Dual Mode Thermometer, Model TH095, FT90, INFRARED EAR THERMOMETER, Infrared Ear Thermometer Probe Cover, Model MDS9701, Infrared Ear Thermometer Probe Cover, Model PC 840, Infrared Ear Thermometer Probe Cover, Model PC7200, Infrared Ear Thermometer Probe Cover, Model PCL A40 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Contract manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2017 | K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| February 28, 2002 | K020504 | INFRARED EAR THERMOMETER, MODELS TH88 SERIES | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 9, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.