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Home›China›Wuxi Kaishun Medical Device Manufacturing Co., Ltd

Wuxi Kaishun Medical Device Manufacturing Co., Ltd

China · Wuxi Jiangsu
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
4listed device types
Class I 4Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 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
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 States4 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 1 excluded
Manufacturer names merged into this page: Wuxi Kaishun Medical Device Manufacturing Co., Ltd · WUXI KAISHUN MEDICAL APPARATUS AND INSTRUMENTS FACTORY
Same-named companies — This database also contains companies with near-identical names: WUXI KAISHUN MEDICAL APPARATUS AND INSTRUMENTS FACTORY. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Wuxi Jiangsu

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 listed device types

Container, Specimen, Non-Sterile 1Percussor 1Stethoscope, Manual 1Tourniquet, Nonpneumatic 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10369460180ESTETOSCOPIOClass I
BR10369460182ESTETOSCÓPIO BIAURICULAR SOLIDORClass I

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