HomeTaiwanQuanta Computer Inc.

Quanta Computer Inc.

Taiwan · Taoyuan · qoca.net
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 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
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 5 510(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
2active device licences
Class II 2
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 Union10 raw hits, 10 excluded, 0 confirmed
United States1 registration records, 5 510(k), 0 PMA, 5 excluded
United Kingdom0 confirmed, 5 excluded
Brazil0 confirmed, 1 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: Quanta Computer Inc · QUANTA COMPUTER INC.

Company information

Country
Taiwan
City
Taoyuan
Website
qoca.net
Product categories
Digital Medicine, Data & Artificial IntelligenceWearables

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 510(k) clearances by year

12008 · K083078
12009 · K083079
12022 · K210179
12023 · K221868
12024 · K231855

FDA listed device types

Frame, Spectacle 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231855QOCA® image Smart RT Contouring System2024-02-13
USK221868QOCA image Smart CXR Image Processing System2023-01-27
USK210179QOCA Portable ECG Monitoring Device2022-08-02
CA96635QUANTA WEARABLE ECG MONITORING DEVICEClass II
CA100072SMART WEARABLE ECG MONITORING DEVICEClass II

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