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ARKRAY, INC.

Japan · Kamigyo-Ku Ky?To

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

24listed device types

Class I 14Class II 10Class III 0

plus 18 registration records and 18 510(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

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States18 registration records, 18 510(k), 0 PMA, 7 excluded

Brazil0 confirmed, 3 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: ARKRAY, INC.

FDA 510(k) clearances by year

12002

12003

32004

42005

22006

12009

12013

12016

22022

12023

12024

FDA listed device types

showing 8 of 24

Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 1Dye-Indicator, Ph (Urinary, Non-Quantitative) 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Urinalysis Controls (Assayed And Unassayed) 1Automated Urinalysis System 1Test, Urine Leukocyte 1Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232416	AUTION EYE AI-4510 Urine Particle Analysis System	2024-05-03
US	K193514	AUTION MAX AX-4060 Urinalysis System	2023-04-13
US	K221175	Multi-Lancet Device 2, ReliOn Premier Lancing Device	2022-10-17

ARKRAY, 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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