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Seoil Pacific Corp.

Korea, Republic · Seoul · www.comfortcough.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN KR-MF-000012478

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel, Russia — 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

5UDI-DI device records

Class IIa 4Class IIb 1

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

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

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 Union5 raw hits, 0 excluded, 5 confirmed

United States1 registration records, 1 510(k), 0 PMA

United Kingdom2 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: SEOIL PACIFIC CORP · SEOIL PACIFIC CORP.

Regulatory identity

EU manufacturer SRN: KR-MF-000012478
EU authorised representative: Advena Limited
UK responsible person: OMC MEDICAL Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809517011514	COMFORT COUGH II	Class IIb
EU	08809517012016	COMFORT HI-FLOW	Class IIa
EU	08809517011170	COMFORT COUGH	Class IIa
EU	08809517011019	COMFORT COUGH	Class IIa
UK	36998	COMFORT COUGH II	Class IIa
UK	57828	COMFORT HI-FLOW	Class IIa
US	K113549	COMFORT COUGH	2013-02-21
BR	80117580799	COMFORT COUGH II	Class II

Seoil Pacific Corp.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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