HomeHong KongTruly Instrument Co., Ltd.

Truly Instrument Co., Ltd.

Hong Kong · Hong Kong
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Australia — 4 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
3listed device types
Class I 1Class II 2Class III 0
plus 11 registration records and 10 510(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
0active device licences
2 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
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.

United States11 registration records, 10 510(k), 0 PMA
Manufacturer names merged into this page: TRULY INSTRUMENT LIMITED

Company information

Country
Hong Kong
City
Hong Kong

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
32009
22012
12016
12017
12019
12023

FDA listed device types

Continuous Measurement Thermometer 1System, Measurement, Blood-Pressure, Non-Invasive 1Toothbrush, Ionic, Battery-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220276Infrared Thermometer TET-3512023-02-17
USK192023Arm Blood Pressure Monitor2019-12-23
USK170545Automatic Wrist Bluetooth Blood Pressure Monitor2017-11-21

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