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Woo Young Medical Co., Ltd.

Korea, Republic · Chungcheongbuk-do · wooyoungmed.com

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, 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

0UDI-DI device records

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIb 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

6active device licences

Class II 6

11 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 3IIb 2

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 2b 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.

Australia, Hong Kong, Singapore: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 Union6,220 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 1 510(k), 0 PMA, 4 excluded

United Kingdom2 confirmed, 9 excluded

Brazil1 confirmed, 2 excluded

Canada6 confirmed, 0 excluded

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

Regulatory identity

UK responsible person: Vygon (UK) Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
UK	46542	Disposable silicone balloon infuser	Class IIb
UK	46542	Disposable silicone balloon infuser	Class IIb
US	K210929	MagiCath II	2022-09-13
BR	10210690021	INFUSOR ELASTÓMERICO DESCARTÁVEL ACCUFUSER	Class II
CA	35925	ACCUFUSER	Class II
CA	73115	ACCUFUSER	Class II
CA	73116	ACCUFUSER VARICON	Class II

Woo Young Medical Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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