HomeChinaJIANGSU BAIDE MEDICAL INSTRUMENT CO., LTD.

JIANGSU BAIDE MEDICAL INSTRUMENT CO., LTD.

China · Zhangjiagang Jiangsu
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
36registered devices
Class I 30Class II 6
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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 States1 registration records, 1 510(k), 0 PMA
Brazil36 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: JIANGSU BAIDE MEDICAL INSTRUMENT CO.,LTD. · JIANGSU BAIDE MEDICAL INSTRUMENT CO., LTD · JIANGSU BAIDE MEDICAL INSTRUMENT CO LTDA · JIANGSU BAIDE MEDICAL INSTRUMENT CO., LTD. · Jiangsu Baide Medical Instrument CO.Ltd · Jiangsu BaiDe Medical Instrument Co. Ltd
Same-named companies — This database also contains companies with near-identical names: Jiangsu Baide Medical Intrument Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Zhangjiagang 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 510(k) clearances by year

12015 · K150009

FDA listed device types

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150009Baide2015-02-25
BR80638419009MICROMOTOR ORTOPÉDICOClass II
BR80638410016INSTRUMENTAL CIRÚRGICO NÃO ARTICULADO CORTANTE - QUANTUMClass II
BR80638410019INSTRUMENTAL CIRÚRGICO NÃO ARTICULADO NÃO CORTANTE AÇO INOX - QUANTUMClass I
SAME0000006462SFDAA00032BT Power Drill handpiece

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