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CONWELL MEDICAL Co., Ltd.

Taiwan · Taichung · www.conwellmedical.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN TW-MF-000012101

This company has registrations in European Union, Saudi Arabia, Australia, Israel — 4 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

105registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union456 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

Saudi Arabia105 confirmed, 0 excluded

Manufacturer names merged into this page: Conwell Medical Co., Ltd.

Regulatory identity

EU manufacturer SRN: TW-MF-000012101
EU authorised representative: MedNet EC-REP GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719878937573	Conwell	Class I
EU	04719878937566	Conwell	Class I
EU	04719878937559	Conwell	Class I
EU	04719878937542	Conwell	Class I
SA	ME0000006483SFDAA00001	PLASTIC ADJUSTABLE COLLAR	—
SA	ME0000006483SFDAA00001	PLASTIC ADJUSTABLE COLLAR	—

CONWELL MEDICAL Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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