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Home›Taiwan›Trividia Health Taiwan, INC.

Trividia Health Taiwan, INC.

Taiwan · Hsinchu City
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
pendingnot queried
USUnited StatesFDA openFDA
10listed device types
Class I 3Class II 7Class III 0
plus 21 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
13active device licences
Class II 5Class III 8
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
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.

United States21 registration records, 3 510(k), 0 PMA
Canada13 confirmed, 0 excluded
Manufacturer names merged into this page: Trividia Health Taiwan, INC. · Trividia Health, Inc. · TRIVIDIA HEALTH, INC.
Same-named companies — This database also contains companies with near-identical names: Trividia Health, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Taiwan
City
Hsinchu City

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

12016 · K143548
12022 · K221072
12026 · K262116

FDA listed device types

showing 8 of 10
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Syringe, Piston 1Multiple Use Blood Lancet For Single Patient Use Only 1Needle, Hypodermic, Single Lumen 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK262116TRUE METRIX Self Monitoring Blood Glucose System2026-07-23
USK221072TRUEdraw Lancing Device, Mini Lancing Device2022-10-18
USK143548TRUE METRIX GO Self Monitoring Blood Glucose System2016-04-01
CA8742PRESTIGE SMART SYSTEM BLOOD GLUCOSE SYSTEMClass III
CA37177PRESTIGE SMART SYSTEM LANCETSClass II
CA37178TRUEDRAW LANCING DEVICEClass II

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