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Home›China›Chongqing Sunkingdom Medical Instrument Company LTD

Chongqing Sunkingdom Medical Instrument Company LTD

China · Chongqing
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
11listed device types
Class I 5Class II 6Class III 0
plus 10 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class I 7Class II 2
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
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States10 registration records, 3 510(k), 0 PMA
Brazil9 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD · CHONGQING SUNKINGDOM MEDICAL INSTRUMENTS CO. LTD. · CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD. · ChongQing Sunkingdom Medical instrument Co., Ltd. · Chongqing Sunkingdom Medical Instrument Company LTD
Same-named companies — This database also contains companies with near-identical names: CHONGQING SUNKINGDOM MEDICAL INSTRUMENTS CO. LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Chongqing

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

12018 · K182306
12019 · K191314
12023 · K222787

FDA listed device types

showing 8 of 11
Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Camera, Ophthalmic, General-Use 1Biomicroscope, Slit-Lamp, Ac-Powered, Exempt 1Biomicroscope, Slit-Lamp, Ac-Powered 1Tonometer, Manual 1Chart, Visual Acuity 1Topographer, Corneal, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P2023-01-09
USK191314Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q2019-12-19
USK182306Sunkingdom Slit Lamp2018-11-22
BR81793140030TONÔMETRO DE APLANAÇÃOClass I
BR80042559019Analisador de Superfície OcularClass II
BR81223800001LÂMPADA DE FENDAClass I
SAME0000000245SFDAA00010Slit Lamp—
SAME0000000245SFDAA00011SLIT LAMP—

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