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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 6 of 7

Device	Model / Reference	Registries	Class	Status
SPOTCHEM II Amylase	77174	EUDAMED	IVD General	Active
Glucocard Sm Control	102525	EUDAMED	IVD Annex II List B	Active
The Lab 001 (CE-8810)	108223	EUDAMED	Class A	Active
Glucocard W (gt-7210)	109052	EUDAMED	IVD Annex II List B	Active
Aution Eleven (ae-4020)	102676	EUDAMED	IVD General	Active
Spotchem D Glu	77944	EUDAMED	IVD General	Active
GLUCOCARD Vital (GT-1050)	46907	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Test Strips	109332	EUDAMED	IVD Annex II List B	Active
Spotchem Ii Gpt/Alt	77170	EUDAMED	IVD General	Active
GLUCOCARD W Test Strips	103710	EUDAMED	IVD Annex II List B	Active
GLUCOCARD W Control Solution	108492	EUDAMED	IVD Annex II List B	Active
Glucocard S (gt-7110)	109311	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Total Protein	77402	EUDAMED	IVD General	Active
Glucocard Mx Blood Glucose Test Strips	78313	EUDAMED	IVD Annex II List B	Active
Glucocard Sm Test Strips	102328	EUDAMED	IVD Annex II List B	Active
Washing Solution (Concentration)	70302	EUDAMED	IVD General	Active
W0101060101	77742	EUDAMED	IVD Annex II List B	Active
SPOTCHEM i-Pack CRP Wide	77610	EUDAMED	IVD General	Active
ADAMS A1c (HA-8380V)	101622	EUDAMED	IVD General	Active
Spotchem D Un	77955	EUDAMED	IVD General	Active
Glucocard Mx Control	78318	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Test Strips	101076	EUDAMED	IVD Annex II List B	Active
Eluent 80a	71262	EUDAMED	IVD General	Active
AUTION EYE Sheath Solution	107665	EUDAMED	Class A	Active
SPOTCHEM D Metabolic2	102731	EUDAMED	IVD General	Active
Adams A1c Control	108931	EUDAMED	IVD General	Active
AUTION EYE Sheath Solution	108523	EUDAMED	Class A	Active
Centrifuge Cup (for D-Concept)	108240	EUDAMED	Class A	Active
GLUCOCARD S Test Strips	109215	EUDAMED	IVD Annex II List B	Active
SpotChem D-Concept 2e (SD-4840)	110046	EUDAMED	Class A	Active
Concentrated Washing Solution 3	108847	EUDAMED	Class A	Active
Glucocard Sm (gt-7120)	47396	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Fructosamine	77413	EUDAMED	IVD General	Active
Spotchem Ii Ggt	77175	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	101471	EUDAMED	IVD Annex II List B	Active
GLUCOCARD X-sensor	78726	EUDAMED	IVD Annex II List B	Active
Column Unit 80	71273	EUDAMED	IVD General	Active
GLUCOCARD X-mini plus (GT-1960)	100477	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Electrolyte (Na, K, Cl)	77963	EUDAMED	IVD General	Active
SPOTCHEM II Kidney-3	102727	EUDAMED	IVD General	Active
Glucocard S (gt-7110)	109523	EUDAMED	IVD Annex II List B	Active
PocketChem UA (PU-4010)	107334	EUDAMED	Class A	Active
GLUCOCARD X-meter CONTROL	78480	EUDAMED	IVD Annex II List B	Active
PocketChem Printer	107856	EUDAMED	Class A	Active
The Lab 004 ALT (GPT)	106405	EUDAMED	IVD General	Active
Glucocard S (gt-7110)	101954	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S onyx (GT-7120)	109323	EUDAMED	IVD Annex II List B	Active
Washing Solution (Concentrate)	109114	EUDAMED	Class A	Active
SPOTCHEM II Creatinine	77412	EUDAMED	IVD General	Active
ADAMS A1c (HA-8180)	34103	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

ARKRAY Europe, B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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