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Arkray USA, Inc.

USA · Edina

✓ Record-verifiedregistrations found in 3 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

32listed device types

Class I 15Class II 17Class III 0

plus 43 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

4active device licences

Class II 3Class III 1

5 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States43 registration records, 10 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 3 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: ARKRAY FACTORY USA, INC.

FDA 510(k) clearances by year

12006

12007

22008 · K082417

42009 · K092104

12010 · K093819

12011 · K110709

FDA listed device types

showing 8 of 32

Prescription Use Blood Glucose Meter For Near-Patient Testing 1Counter, Differential Cell 1Hemoglobin A1c Test System 1Glucose Oxidase, Glucose 1Blood, Occult, Colorimetric, In Urine 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Calibrator, Secondary 1Counter, Urine Particle 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110709	ARK CARE DIABETES MANAGMENT SYSTEM	2011-05-19
US	K093819	ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)	2010-06-09
US	K092104	ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM	2009-11-24
CA	1988	DIASCREEN REAGENT STRIPS FOR URINALYSIS	Class II
CA	35067	DIASCREEN 50 URINE CHEMISTRY ANALYZER	Class II
CA	60099	TECHLITE LANCETS	Class II

Arkray USA, Inc.

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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