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Taewoong Medical Co., Ltd.

Korea, Republic · Gimpo-Si

✓ Record-verifiedregistrations found in 9 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 2Class II 8Class III 0

plus 19 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

23 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

17 including historic records

TWTaiwanTFDA

9valid device licences

Class II 8Class III 1

SGSingaporeHSA SMDR

13device registrations

CLASS B 1CLASS C 12

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIb 5

HKHong KongMDACS

26valid listings

Class III 26

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 2Class 3 3

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 States19 registration records, 17 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: TAEWOONG MEDICAL CO., LTD · TAEWOONG MEDICAL CO.,LTD. · Taewoong Medical Co., Ltd. · Taewoong Medical Co., Ltd · TAEWOONG MEDICAL CO. LTD

FDA 510(k) clearances by year

12005

12008

12009

12012

12013

12021

22022

32023

12024

32025

22026

FDA listed device types

showing 8 of 10

Pancreatic Stent, Covered, Metallic, Removable 1Gallbladder Drainage Stent And Delivery System 1Prosthesis, Esophageal 1Endoscopic Guidewire, Gastroenterology-Urology 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1Stent, Colonic, Metallic, Expandable 1Stents, Drains And Dilators For The Biliary Ducts 1Stent, Metallic, Expandable, Duodenal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260962	Sphincterotome	2026-05-21
US	K252648	Niti-S SPAXUS Stent	2026-03-13
US	K251123	Niti-S Biliary Stent; Niti-S Biliary Slim M Stent	2025-12-29
CA	91990	UVENTA URETERAL STENT	Class III
CA	97318	UVENTA URETHRAL STENT	Class III

Taewoong Medical 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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