Home›Korea, Republic›Seawon Meditech Co., Ltd

Seawon Meditech Co., Ltd

Korea, Republic · Gyeonggi-do · www.seawonmt.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN KR-MF-000007442

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

163UDI-DI device records

Class IIa 83Class IIb 80

USUnited StatesFDA openFDA

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

19registered device records

Class I 1Class IIa 6Class IIb 11System or Procedure Pack 1

BRBrazilANVISA

16registered devices

Class I 2Class II 14

38 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

8valid device licences

Class I 1Class II 7

SGSingaporeHSA SMDR

8device registrations

CLASS B 8

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

2valid listings

Class II 1Class 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 Union163 raw hits, 0 excluded, 163 confirmed

United States9 registration records, 0 510(k), 0 PMA

United Kingdom19 confirmed, 0 excluded

Brazil16 confirmed, 0 excluded

Manufacturer names merged into this page: SEAWON MEDITECH CO., LTD. · SEAWON MEDITECH CO., LTD · SEAWON Meditech co., Ltd.

Regulatory identity

EU manufacturer SRN: KR-MF-000007442
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

FDA listed device types

showing 8 of 9

Device, Percutaneous, Biopsy 1Cannula, Surgical, General & Plastic Surgery 1Bit, Drill 1Extractor 1Dispenser, Cement 1Holder, Needle; Orthopedic 1Injector, Vertebroplasty (Does Not Contain Cement) 1Passer, Wire, Orthopedic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809272561316	SPASY	Class IIa
EU	08809272563716	ABMC Kit	Class IIa
EU	08809272564010	MIXMAX	Class IIb
EU	08809272562764	MIXMAX	Class IIb
UK	47129	SPASY	Class IIa
UK	61140	SW-PRP	Class IIa
UK	46350	COLEX	Class IIa
BR	80981949010	Kit Cânula Descartável Seeone View Select	Class II
BR	80981940041	CÂNULAS REUTILIZÁVEIS PARA ENDOSCOPIA - SEAWON II	Class I
BR	80981940042	CÂNULAS REUTILIZÁVEIS PARA ENDOSCOPIA - SEAWON	Class I