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ARKRAY Factory, Inc.

Japan·JP-MF-000003008

Last updated September 17, 2026

Information

Country: Japan
Address: 1480, Koji, Konan-cho, Koka-shi, Shiga, Japan
Website: arkray.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Shuzo Joko
EUDAMED SRN: JP-MF-000003008
FDA FEI Number: 3003422726
DUNS Number: —

Catalogue (318)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
AUTION Sticks 10EA	73594	EUDAMED	IVD General	Active
GLUCOCARD X-sensor	78728	EUDAMED	IVD Annex II List B	Active
PocketChem UA (PU-4010)	107332	EUDAMED	Class A	Active
Eluent 80ct	47301	EUDAMED	IVD General	Active
GLUCOCARD G sensor	33699	EUDAMED	IVD Annex II List B	Active
The Lab 004 Urea/BUN	107839	EUDAMED	IVD General	Active
GLUCOCARD W Test Strips	103711	EUDAMED	IVD Annex II List B	Active
Glucocard S (gt-7110)	101494	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Total Cholesterol	77162	EUDAMED	IVD General	Active
Eluent 90cv	105726	EUDAMED	IVD General	Active
SPOTCHEM II Creatinine2	102723	EUDAMED	IVD General	Active
S.G. Calibrator H	100672	EUDAMED	IVD General	Active
GLUCOCARD Σ Test Strips	70192	EUDAMED	IVD Annex II List B	Active
Concentrated Washing Solution 3	107293	EUDAMED	Class A	Active
GLUCOCARD S Test Strips	101073	EUDAMED	IVD Annex II List B	Active
Spotchem D Crp	77805	EUDAMED	IVD General	Active
SpotChem D-Concept 2c (SD-4830)	110044	EUDAMED	Class A	Active
WeCheck for S onyx	109504	EUDAMED	Class A	Active
SPOTCHEM II Liver-1	77182	EUDAMED	IVD General	Active
GLUCOCARD S Control Solution	108499	EUDAMED	IVD Annex II List B	Active
The Lab 004 CRE	105587	EUDAMED	IVD General	Active
SPOTCHEM D Total-B	77961	EUDAMED	IVD General	Active
Osmo Station (om-6060)	60703	EUDAMED	IVD General	Active
Eluent 80ct	71292	EUDAMED	IVD General	Active
GLUCOCARD X-sensor	78722	EUDAMED	IVD Annex II List B	Active
Glucocard Mx Blood Glucose Test Strips	78314	EUDAMED	IVD Annex II List B	Active
AUTION EYE Sheath Solution	108526	EUDAMED	Class A	Active
Eluent 80ct	71291	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	109329	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Kidney-2	77422	EUDAMED	IVD General	Active
HEMOLYSIS WASHING SOLUTION Lite H	107378	EUDAMED	Class A	Active
GLUCOCARD S Test Strips	103461	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Control Solution	102634	EUDAMED	IVD Annex II List B	Active
Hemolysis Washing Solution 90h	107374	EUDAMED	Class A	Active
SPOTCHEM E-Plate	77083	EUDAMED	IVD General	Active
Spotchem Ii Kenshin-2	77188	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	101473	EUDAMED	IVD Annex II List B	Active
Spotchem Ez (sp-4430)	18304	EUDAMED	IVD General	Active
GLUCOCARD W Blood Glucose Monitoring System	K170064	FDA 510(k)	Class II	Active
GLUCOCARD® W onyx Blood Glucose Monitoring System	K183306	FDA 510(k)	Class II	Active
ADAMS A1c HA-8180V, CALIBRATOR 80	K162822	FDA 510(k)	Class II	Active
Arkray Glucocard 01 Blood Glucose Monitoring System And Relion Confirm Blood Glucose Monitoring System	K124021	FDA 510(k)	Class II	Active
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System	K142336	FDA 510(k)	Class II	Active
Glucocard 01-Mini Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System	K142035	FDA 510(k)	Class II	Active
ADAMS A1c (HA-8180V)	34111	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	105902	EUDAMED	IVD Annex II List B	Active
Spotchem Ii Ggt	77410	EUDAMED	IVD General	Active
SPOTCHEM II Amylase2	109081	EUDAMED	IVD General	Active
Column Unit 80t	71289	EUDAMED	IVD General	Active
Spotchem D-01 Set	105285	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

ARKRAY Europe, B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.