HomeChinaGuangdong Kingfa Sci. & Tech.Co., Ltd.

Guangdong Kingfa Sci. & Tech.Co., Ltd.

China · Qingyuan
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Russia — 6 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
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
3registered 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
7active ARTG entries
Class I 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 Arabia3 confirmed, 0 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. · Shandong KINGFA Sci.& tech .co · GUANGDONG KINGFA SCIENCE AND TECHNOLOGY CO.,LTD
Same-named companies — This database also contains companies with near-identical names: GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD., GUANGDONG KINGFA SCIENCE AND TECHNOLOGY CO.,LTD, Shandong KINGFA Sci.& tech .co. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Qingyuan

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
SAME0000000102SFDAA00016Disposable Nitrile Examination Gloves
SAME0000002792SFDAA00008SAFEMAX NITRILE EXAMINATION GLOVES

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