HomeChinaKUNSHAN RADIANT INNOVATION CO., LTD.

KUNSHAN RADIANT INNOVATION CO., LTD.

China · Jiangsu Province
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 24 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
8 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States24 registration records, 15 510(k), 0 PMA, 5 excluded
Brazil2 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: RADIANT INNOVATION INC. · KUNSHAN RADIANT INNOVATION CO., LTD. · KUNSHAN RADIANT INNOVATION CO., LTD
Same-named companies — This database also contains companies with near-identical names: Radiant Innovation, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Jiangsu Province

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12001
12002
12003
12004
12005
12006
12007
32010
12011
12012
12017
12018
12024

FDA listed device types

Clinical Electronic Thermometer 1Continuous Measurement Thermometer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)2024-06-05
USK163601RII Smart IR Thermometer2018-12-06
USK162083RII Multi-function Infrared Thermometer, Model TH52Z2017-01-09
BR80581060001TERMÔMETRO AURICULARClass II
BR10343209033TERMÔMETRO CLÍNICO INFRAVERMELHOClass II

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