HomeChinaHANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.

HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.

China · Hangzhou Zhejiang
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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
27listed device types
Class I 22Class II 5Class III 0
plus 29 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
79registered devices
Class I 38Class II 41
88 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class I 1Class II 3
SGSingaporeHSA SMDR
2device registrations
CLASS B 1CLASS C 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 1Manufacturing 2
AUAustraliaTGA ARTG
22active ARTG entries
Class I 3IIa 9IIb 10
HKHong KongMDACS
2valid listings
Class II 1Class III 1
ILIsraelAMAR
4registrations
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 States29 registration records, 3 510(k), 0 PMA
Brazil79 confirmed, 1 excluded
Manufacturer names merged into this page: HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD. · Hangzhou Kangji Medical Instrument Co., Ltd.

Company information

Country
China
City
Hangzhou Zhejiang

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

12023 · K232401
12024 · K233263
12025 · K250643

FDA listed device types

showing 8 of 27
Forceps 1Instrument, Ent Manual Surgical 1Container, Specimen, Sterile 1Instrument, Ligature Passing And Knot Tying 1Applier, Hemostatic Clip 1Needle, Aspiration And Injection, Reusable 1Instrument, Cutting, Orthopedic 1Clamp, Uterine 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250643Disposable Polymer Ligation Clips2025-11-20
USK233263Disposable Trocars2024-04-09
USK232401Disposable Veress Needles2023-12-14
BR80082910254CLIPADORA MULTI-FIRE PARA CLIPS DE LIGAÇÃO - CLIPFIXClass I
BR80082910255SISTEMA DE CLIPADORAS ARTICULADAS CLIPFIX TAIMINClass I
BR80082919078BOLSA COLETORA ENDOBAG TAIMINClass II

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