HomeChinaJIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.

JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.

China · Ji 'An Jiangxi
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia — 6 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
8listed device types
Class I 5Class II 3Class III 0
plus 8 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
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 States8 registration records, 1 510(k), 0 PMA
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD. · JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD

Company information

Country
China
City
Ji 'An Jiangxi

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

12025 · K241005

FDA listed device types

Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Endoscopic Bite Block 1Valve, Switching (Ploss) 1Clamp, Surgical, General & Plastic Surgery 1Hemostatic Metal Clip For The Gi Tract 1Dislodger, Stone, Basket, Ureteral, Metal 1Bottle, Collection, Vacuum 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241005Haemostasis Clips2025-01-02
BR81251089015Bainha de Acesso Ureteral com Sucção ENDOSURG (modelo Y-Type)Class II
BR81251089006Fio Guia Hidrofílico EndosurgClass II
BR81251089007Fio Guia Zebra EndosurgClass II

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