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Home›USA›Wujiang City Hua Xin Medical Appliance Co., Ltd.

Wujiang City Hua Xin Medical Appliance Co., Ltd.

USA · Candler
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 4Class II 1Class III 0
plus 11 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
31registered devices
Class I 8Class II 23
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
2active device licences
Class II 2
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIa 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 States11 registration records, 2 510(k), 0 PMA, 3 excluded
Brazil31 confirmed, 10 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: Wujiang City Shen Ling Medical Device Co.,Ltd. · WUJIANG CITY CLOUD & DRAGON MEDICAL DEVICE CO., LTD · WUJIANG CITY WORLDFUL TRADE CO., LTD · WUJIANG CITY SHEN LING MEDICAL DEVICE CO., LTD. · WUJIANG CITY SHENLONG MEDICAL HEALTH PRODUCT CO. LTD. · WUJIANG CITY SHENLI MEDICAL & HEALTH MATERIAL CO., LTD.

Company information

Country
USA
City
Candler

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

22002 · K013926

FDA listed device types

Tape And Bandage, Adhesive 1Device, Pressure Applying 1Brush, Dermabrasion, Manual 1Pack, Heat, Moist 1Needle, Acupuncture, Single Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK013926QIZHOU ACUPUNCTURE NEEDLE2002-07-18
USK021095HOLY DRAGON BRAND ACUPUNCTURE NEEDLES2002-05-17
BR80412419001AGULHAS PARA ACUPUNTURA TAIYITCMClass II
BR81616219003Zhen - Agulha colorClass II
BR81616219005BK PRIMEClass II
CA98939ACUPUNCTURE NEEDLESClass II
CA73871STERILE DISPOSABLE ACUPUNCTURE NEEDLES - STAINLESS STEELClass II

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