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Ixensor Company , Ltd.

Taiwan · Taipei

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Singapore, 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 5Class II 3Class III 0

plus 8 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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 1 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States8 registration records, 3 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: IXENSOR CO LTD

FDA 510(k) clearances by year

12017 · K163087

22019 · K192369

FDA listed device types

Ventilatory Effort Recorder 1Assay, Glycosylated Hemoglobin 1System, Test, Blood Glucose, Over The Counter 1Test, Luteinizing Hormone (Lh), Over The Counter 1Enzymatic Esterase--Oxidase, Cholesterol 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Ldl & Vldl Precipitation, Hdl 1Colorimetric Method, Triglycerides 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192369	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	2019-10-29
US	K181915	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit	2019-04-12
US	K163087	PixoTest Blood Glucose Monitoring System	2017-11-02

Ixensor Company , 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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