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DK Medical Technology Co., Ltd.

China · Suzhou Jiangsu

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Singapore, Hong Kong — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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 B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

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 States3 registration records, 3 510(k), 0 PMA, 9 excluded

Brazil3 confirmed, 1 excluded

Manufacturer names merged into this page: DK Medical Technology Co., Ltd. · DK MEDICAL TECHNOLOGY CO., LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242254	D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter	2025-04-21
US	K232207	D·Kutting PTA Scoring Balloon Dilatation Catheter	2024-03-07
US	K214009	D·Kaptain PTA High Pressure Balloon Dilatation Catheter	2023-04-05
BR	80047309251	Cateter de dilatação com balão de escorificação periférico D·Kutting	Class II
BR	80047309252	Cateter de dilatação com balão de escorificação periférico - D·Kutting	Class II
BR	80047309253	Cateter de Dilatação por Balão de Alta Pressão PTA D·Kaptain	Class II

DK Medical Technology Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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