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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 3 of 7

Device	Model / Reference	Registries	Class	Status
SPOTCHEM II Kidney-2	77187	EUDAMED	IVD General	Active
GLUCOCARD W Test Strips	108483	EUDAMED	IVD Annex II List B	Active
Spotchem D Alt (gpt)	77936	EUDAMED	IVD General	Active
SPOTCHEM II Total Bilirubin	77400	EUDAMED	IVD General	Active
SPOTCHEM II Glucose	77395	EUDAMED	IVD General	Active
SPOTCHEM II Calcium	77166	EUDAMED	IVD General	Active
Spotchem D Ast (got)	77938	EUDAMED	IVD General	Active
Whole Blood Sample Tube	108242	EUDAMED	Class A	Active
Spotchem Ii Alp	77411	EUDAMED	IVD General	Active
Osmo Station (om-6050)	60503	EUDAMED	IVD General	Active
Spotchem D-01 (sd-3810)	17503	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	101718	EUDAMED	IVD Annex II List B	Active
GLUCOCARD X-sensor	100621	EUDAMED	IVD Annex II List B	Active
Osmo Station 2 (om-6070)	109223	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	108495	EUDAMED	IVD Annex II List B	Active
AUTION EYE Sheath Solution	105582	EUDAMED	IVD General	Active
GLUCOCARD X-meter (GT-1910)	47536	EUDAMED	IVD Annex II List B	Active
GLUCOCARD X-sensor	78711	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Ca	77939	EUDAMED	IVD General	Active
AutionIDaten (AE-4070)	108412	EUDAMED	Class A	Active
GLUCOCARD S onyx (GT-7120)	108480	EUDAMED	IVD Annex II List B	Active
HEMOLYSIS WASHING SOLUTION Lite H	101712	EUDAMED	IVD General	Active
Eluent 90b	105725	EUDAMED	IVD General	Active
SPOTCHEM II Total Cholesterol	77397	EUDAMED	IVD General	Active
AUTION EYE Control Solution	105638	EUDAMED	IVD General	Active
AUTION EYE Calibrator	105639	EUDAMED	IVD General	Active
Spotchem Ii Ldh	77406	EUDAMED	IVD General	Active
SPOTCHEM D Control	77966	EUDAMED	IVD General	Active
SPOTCHEM II Heart-2	77186	EUDAMED	IVD General	Active
Centrifuge Tube (for SPOTCHEM EZ)	108243	EUDAMED	Class A	Active
Lactate Pro 2 (LT-1730)	48302	EUDAMED	IVD devices for self-testing	Active
AUTION Diluent (SED)	73807	EUDAMED	IVD General	Active
SPOTCHEM II Calcium2	109211	EUDAMED	IVD General	Active
GLUCOCARD X-mini plus (GT-1960)	46745	EUDAMED	IVD Annex II List B	Active
Ammonia Test Kit Ii	75304	EUDAMED	IVD General	Active
Spotchem Calibration Check	77043	EUDAMED	IVD General	Active
Glucocard Mx Blood Glucose Test Strips	78315	EUDAMED	IVD Annex II List B	Active
Cuvette (heparin)	108239	EUDAMED	Class A	Active
Column Unit 80t	47300	EUDAMED	IVD General	Active
Column Unit 80	71261	EUDAMED	IVD General	Active
Concentrated Washing Solution 3	79053	EUDAMED	IVD General	Active
Column Unit 90	105723	EUDAMED	IVD General	Active
SPOTCHEM D Mg	77949	EUDAMED	IVD General	Active
SPOTCHEM D Kidney2	102730	EUDAMED	IVD General	Active
Spotchem D Alb	77934	EUDAMED	IVD General	Active
SPOTCHEM Electrolyte Control [Na, K, Cl]	77967	EUDAMED	IVD General	Active
Spotchem Ii Ldh	77171	EUDAMED	IVD General	Active
ADAMS A1c (HA-8180V)	34109	EUDAMED	IVD General	Active
GLUCOCARD W Control Solution	108490	EUDAMED	IVD Annex II List B	Active
Hemolysis Washing Solution 80h	71276	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.