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Sewoon Medical Co., Ltd.

Korea, Republic · Cheonana-si · www.sewoonmedical.co.kr

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Hong Kong, Israel — 8 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

0UDI-DI device records

USUnited StatesFDA openFDA

10listed device types

Class I 4Class II 6Class III 0

plus 12 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class IIb 9

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

19valid device licences

Class I 5Class II 14

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 1Manufacturing 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

Class II 3Class III 1

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 States12 registration records, 1 510(k), 0 PMA

United Kingdom9 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: SEWOON MEDICAL CO., LTD. · SEWOON MEDICAL.CO., LTD.

Regulatory identity

UK responsible person: Obelis UK Ltd

Business registration

KRX ticker code: 100700
Registration status: Active
Incorporated: 2008-09-30

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12002 · K013276

FDA listed device types

showing 8 of 10

Urinary Drainage Collection Kit, For Indwelling Catheter 1Catheter And Tip, Suction 1Prosthesis, Esophageal 1Prosthesis, Tracheal, Expandable 1Catheter, Retention Type, Balloon 1Stents, Drains And Dilators For The Biliary Ducts 1Bag, Drainage, With Adhesive, Ostomy 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	43691	BONASTENT® Biliary M-Hilar (Point Radio) Uncovered	Class IIb
UK	37847	BONASTENT® Colo-Rectal Uncovered	Class IIb
UK	32640	BONASTENT® Duodenal/Pyloric M-Duodenal Uncovered	Class IIb
US	K013276	ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)	2002-02-15
BR	81565149021	Sistema de drenagem "BAROVAC"	Class II