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Vitaltec Corporation Co., Ltd.

Taiwan · Taichung · www.vitaltec-corp.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN TW-MF-000011422

This company has registrations in European Union, United States, Brazil, Singapore, Israel — 5 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

8UDI-DI device records

Class IIa 2Class IIb 6

USUnited StatesFDA openFDA

4listed device types

Class I 3Class II 1Class III 0

plus 4 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

5registered devices

Class I 1Class II 4

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

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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 Union8 raw hits, 0 excluded, 8 confirmed

United States4 registration records, 2 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: VITALTEC CORPORATION · Vitaltec Corporation

Regulatory identity

EU manufacturer SRN: TW-MF-000011422
EU authorised representative: CMC Medical Devices & Drugs SL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04711467491336	Rota-Trach Disposable Standard Tracheostomy Tube	Class IIb
EU	04711467491176	Rota-Trach Disposable Standard Tracheostomy Tube	Class IIb
EU	04711467491626	Rota-Trach Inner Cannula Tracheostomy Tube	Class IIb
EU	04711467490100	Vital-Cath Closed Suction System	Class IIa
US	K242921	5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm	2025-06-10
US	K100480	ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH	2010-06-11
BR	80037520028	VITALCATH	Class II
BR	80037520053	VITALCATH	Class II
BR	80037520047	TUBO DE TRAQUEOSTOMIA COM CÂNULA INTERNA COM CUFF	Class II

Vitaltec Corporation Co., Ltd.

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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