HomeTaiwanBriteMED Technology Inc.

BriteMED Technology Inc.

Taiwan · New Taipei City · www.britemed.com.tw
✓ Record-verifiedregistrations found in 3 marketsEU SRN TW-MF-000028387

This company has registrations in European Union, United States, Australia — 3 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
1UDI-DI device records
Class IIa 1
USUnited StatesFDA openFDA
10listed device types
Class I 3Class II 7Class III 0
plus 15 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
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
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union1 raw hits, 0 excluded, 1 confirmed
United States15 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: BRITEMED TECHNOLOGY INC.

Regulatory identity

EU manufacturer SRN
TW-MF-000028387
EU authorised representative
Obelis s.a.

Company information

Country
Taiwan
City
New Taipei City
Website
www.britemed.com.tw
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentCardiology & vascular medicine

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 10
Cystoscope And Accessories, Flexible/Rigid 1Bronchoscope (Flexible Or Rigid) 1Endoscopic Video Imaging System/Component, Gastroenterology-Urology 1Duodenoscope And Accessories, Flexible/Rigid 1Colonoscope And Accessories, Flexible/Rigid 1Ureteroscope And Accessories, Flexible/Rigid 1Gastroscope And Accessories, Flexible/Rigid 1Accessories, Photographic, For Endoscope (Exclude Light Sources) 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04719873790029PC-Based Resting ECGClass IIa

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