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Changzhou Kangdi Medical Stapler Co., Ltd.

USA · Echo

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Israel, Russia — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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, 4 510(k), 0 PMA

Brazil1 confirmed, 2 excluded

Saudi Arabia0 confirmed, 2 excluded

Manufacturer names merged into this page: CHANGZHOU KANGDI MEDICAL STAPLER CO LTD

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172561	Disposable Circular Stapler	2017-12-05
US	K172538	Disposable Linear Stapler, Disposable Linear Cutter	2017-11-30
US	K121474	DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER	2012-07-16
BR	10349009049	Grampeador Linear Endoscópico Elétrico Descartável	Class II

Changzhou Kangdi Medical Stapler Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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