HomeChinaNanjing Jin Bai HE Medical Apparatus Co., Ltd.

Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

China · Nanjing
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Australia — 3 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
4510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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 States0 registration records, 4 510(k), 0 PMA, 1 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD. · Nanjing Jin Bai He Medical Apparatue Co., Ltd

Company information

Country
China
City
Nanjing

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

12007 · K070451
12011 · K102833
12017 · K170787
12021 · K201196

Registration details (sample)

MarketIdentifierNameClass / date
USK201196Scooter (Model: FDB01)2021-06-25
USK170787Powered Wheelchair DYW30A(D09)2017-08-09
USK102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS2011-11-18
SAME0000018698SFDAA00001Wheelchair, powered
SAME0000013139SFDAA00001Electric Wheelchair

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