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Ya Horng Electronic Co., Ltd.

Taiwan · Tainan

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 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

8listed device types

Class I 1Class II 7Class III 0

plus 6 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

8active device licences

Class II 8

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States6 registration records, 10 510(k), 0 PMA, 2 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: Ya Horng Electronic Co., Ltd. · YAHORNG ELECTRONIC CO., LTD.

FDA 510(k) clearances by year

22004

32005 · K051862

22008 · K081590

12009 · K090058

12012 · K121025

12022 · K221486

FDA listed device types

Analyzer, Body Composition, Exempt 1System, Measurement, Blood-Pressure, Non-Invasive 1Transmitters And Receivers, Electrocardiograph, Telephone 1Clinical Electronic Thermometer 1External Mechanical Stimulator For The Relief Of Congestion 1Electrocardiograph 1Stethoscope, Electronic 1Toothbrush, Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221486	INDEX BPM	2022-08-30
US	K121025	YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION	2012-08-17
US	K090058	YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB	2009-04-22
CA	87930	WITHINGS BLOOD PRESSURE MONITOR	Class II
CA	93198	QARDIOARM BLOOD PRESSURE MONITOR	Class II
CA	97249	A101 BLOOD PRESSURE MONITOR	Class II

Ya Horng Electronic Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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