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ARKRAY Factory, Inc.

Japan · Koka

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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 52 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

45registered devices

Class I 10Class II 35

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

10active device licences

Class II 9Class III 1

22 including historic records

TWTaiwanTFDA

69valid device licences

Class I 35Class II 34

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

32active registrations

Class 1 8Class 2a 22Class 2b 2

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 States52 registration records, 15 510(k), 0 PMA, 5 excluded

Brazil45 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

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

FDA 510(k) clearances by year

12007

22008

42009

12010

12011

32014

22017

12019

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	K183306	GLUCOCARD® W onyx Blood Glucose Monitoring System	2019-04-10
US	K170064	GLUCOCARD W Blood Glucose Monitoring System	2017-08-16
US	K162822	ADAMS A1c HA-8180V, CALIBRATOR 80	2017-06-29
BR	82444370368	ELUENT 90CV	Class I
BR	82444370373	CALIBRATOR 90	Class II
BR	82444370374	Automatic Glycohemoglobin Analyzer ADAMS A1c HA-8190V	Class II
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 Factory, 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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