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CHANGZHOU KANGHUI MEDICAL INNOVATION CO. , LTDA

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in Brazil, Saudi Arabia, Taiwan, South Korea — 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

45registered devices

Class I 45

69 including historic records

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States0 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil45 confirmed, 1 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: CHANGZHOU KANGHUI MEDICAL INNOVATION CO. , LTDA · Changzhou Kanghui Medical Innovation CO., LTD. · CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD · Changzhou Kanghui Medical Innovation Co. Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80082910063	INSTRUMENTAIS DE PEQUENOS E GRANDES FRAGMENTOS	Class I
BR	80082910059	FIXADOR EXTERNO EASY FIX GRANDE	Class I
BR	80082910060	FIXADOR EXTERNO EASY FIX MINI	Class I
SA	ME0000015294SFDAA00002	Suprapatellar Instruments Set	—
SA	ME0000015294SFDAA00003	Standard Instruments Set with Distal Aiming Device	—

CHANGZHOU KANGHUI MEDICAL INNOVATION CO. , LTDA

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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