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Jiangsu Vedkang Medical Science and Technology Co., Ltd.

China · Changzhou

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

20listed device types

Class I 5Class II 15Class III 0

plus 20 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

38registered devices

Class I 10Class II 28

42 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

8 including historic records

TWTaiwanTFDA

15valid device licences

Class I 3Class II 12

SGSingaporeHSA SMDR

6device registrations

CLASS B 5CLASS C 1

KRSouth KoreaMFDS GMP

7GMP quality-system certificates

Import 7

AUAustraliaTGA ARTG

55active ARTG entries

IIa 33IIb 14Class Is (sterile) 8

HKHong KongMDACS

4valid listings

Class II 2Class III 2

ILIsraelAMAR

3registrations

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 States20 registration records, 7 510(k), 0 PMA

Brazil38 confirmed, 0 excluded

Manufacturer names merged into this page: Jiangsu Vedkang Medical Science and Technology Co.,Ltd. · JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD. · JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD · JIANGSU VEDKANG MEDICAL SCIENCE & TECHNOLOGY CO., LTD.

FDA 510(k) clearances by year

22022 · K220089

22023 · K230598

32024 · K232825

FDA listed device types

showing 8 of 20

Forceps, Biopsy, Non-Electric 1Accessories, Cleaning Brushes, For Endoscope 1Endoscopic Bite Block 1Snare, Non-Electrical 1Adaptor, Catheter 1Dislodger, Stone, Basket, Ureteral, Metal 1Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 1Endoscopic Injection Needle, Gastroenterology-Urology 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232825	Disposable Sphincterotome	2024-03-29
US	K232752	Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)	2024-02-26
US	K232245	VedDilator ^TM (3-Stage Balloon Dilation Catheter)	2024-02-15
BR	80286580020	Dilation Balloon Catheter	Class II
BR	80286580021	Bougie Dilator - VDK-BO	Class II
BR	10159030108	insuflador de balão	Class I

Jiangsu Vedkang Medical Science and 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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