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Sejong Medical Co., Ltd

Korea, Republic · Paju-si · www.sejongmedical.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN KR-MF-000020090

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Hong Kong, Israel — 7 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

201UDI-DI device records

Class I 1Class IIa 161Class IIb 39

USUnited StatesFDA openFDA

9510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 4Class IIb 1

BRBrazilANVISA

15registered devices

Class II 15

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

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

4valid listings

Class II 3Class III 1

ILIsraelAMAR

1registrations

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.

European Union201 raw hits, 0 excluded, 201 confirmed

United States0 registration records, 9 510(k), 0 PMA, 2 excluded

United Kingdom5 confirmed, 0 excluded

Brazil15 confirmed, 0 excluded

Manufacturer names merged into this page: SEJONG MEDICAL CO. LTD.

Regulatory identity

EU manufacturer SRN: KR-MF-000020090
EU authorised representative: Obelis s.a.
UK responsible person: IMed Consultancy Ltd

Business registration

KRX ticker code: 258830
Registration status: Active
Incorporated: 2018-05-29

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08806182210488	Laport	Class IIa
EU	08806182210464	Laport	Class IIa
EU	08806182210426	Laport	Class IIa
EU	08806182210402	Laport	Class IIa
UK	61875	Lap-ix	Class IIb
UK	42412	Prima Laport	Class IIa
UK	38456	Lapsingle	Class IIa
US	K253165	LAP-iX2N	2026-06-09
US	K252985	Laport	2026-05-19
US	K200639	LAP-iX	2021-09-29
BR	81231559057	Cânula Trocarter Multiport	Class II
BR	81231559058	Bolsa Coletora Lapbag	Class II
BR	81231559005	Cânula Trocarte Ultra flexível com Válvula sem Lâmina	Class II

Sejong Medical Co., Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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