HomeGUANGDONG KINGFA SCIENCE AND TECHNOLOGY CO.,LTD

GUANGDONG KINGFA SCIENCE AND TECHNOLOGY CO.,LTD

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 4Class II 1Class III 0
plus 8 registration records and 14 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States8 registration records, 14 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia2 confirmed, 1 excluded
Manufacturer names merged into this page: GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD. · GUANGDONG KINGFA SCI.&TECH.CO.,LTD. · GUANGDONG KINGFA SCI & TECH CO. LTD · GUANGDONG KINGFA SCI.& TECH.CO., LTD. · GUANGDONG KINGFA SCIENCE AND TECHNOLOGY CO.,LTD · Guangdong Kingfa Sci & Tech Co., Ltd
Same-named companies — This database also contains companies with near-identical names: GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD., Guangdong Kingfa Sci. & Tech.Co., Ltd., Shandong KINGFA Sci.& tech .co. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

22020
32021
52022 · K222612
32023 · K231155
12024 · K233723

FDA listed device types

Mask, Surgical 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233723Medical surgical mask2024-07-29
USK231155Biodegradable Medical surgical mask2023-11-07
USK221983Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color2023-04-27
BR80117581268Luvas de Exame de Nitrilo Sem PóClass I
SAME0000002792SFDAA00008SAFEMAX NITRILE EXAMINATION GLOVES
SAME0000002208SFDAA00017Layan

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