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SEQUOIA-TWN HEALTHCARE Co., Ltd.

Taiwan · New Taipei City · www.sequoiahealthcare.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN TW-MF-000004174

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel — 6 overseas markets. 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

52UDI-DI device records

Class I 52

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 18

BRBrazilANVISA

2registered devices

Class I 1Class 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 Union52 raw hits, 0 excluded, 52 confirmed

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

United Kingdom18 confirmed, 0 excluded

Brazil2 confirmed, 1 excluded

Manufacturer names merged into this page: SEQUOIA-TWN HEALTHCARE CO. LTD. · SEQUOIA HEALTHCARE CO. LTD

Regulatory identity

EU manufacturer SRN: TW-MF-000004174
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: CMC Medical Devices LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04719879030716	—	Class I
EU	04719879030617	—	Class I
EU	04719879030433	—	Class I
EU	04719879030310	—	Class I
UK	63641	Alternating air mattress(without pump)	Class I
UK	63641	Alternating air mattress(without pump)	Class I
UK	63641	Alternating air mattress(without pump)	Class I
BR	80866380011	COLCHÕES PNEUMÁTICOS	Class II
BR	80172580006	COLCHÃO ELÉTRICO	Class I

SEQUOIA-TWN HEALTHCARE Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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