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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 5 of 7

Device	Model / Reference	Registries	Class	Status
Spotchem D Ld	77948	EUDAMED	IVD General	Active
Eluent 80b	71263	EUDAMED	IVD General	Active
Spotchem Ii Panel-V	77189	EUDAMED	IVD General	Active
Spotchem Ii Panel-1	77419	EUDAMED	IVD General	Active
GLUCOCARD Vital Test Strips	70184	EUDAMED	IVD Annex II List B	Active
Control Dilution Set 80	107350	EUDAMED	Class A	Active
Aution Max (ax-4060)	100525	EUDAMED	IVD General	Active
SPOTCHEM II Amy-wide	100170	EUDAMED	IVD General	Active
SPOTCHEM II Calcium	77487	EUDAMED	IVD General	Active
Spotchem D-03 Set	105289	EUDAMED	IVD General	Active
Hemolysis Washing Solution 80h	107349	EUDAMED	Class A	Active
Eluent 80cv	71279	EUDAMED	IVD General	Active
Eluent 90a	105724	EUDAMED	IVD General	Active
Spotchem D Ggt	77943	EUDAMED	IVD General	Active
Spotchem Ii Got/Ast	77169	EUDAMED	IVD General	Active
Concentrated Washing Solution 3	108846	EUDAMED	Class A	Active
GLUCOCARD S onyx (GT-7120)	109324	EUDAMED	IVD Annex II List B	Active
AUTION Staining Solution (BAC)	73810	EUDAMED	IVD General	Active
SPOTCHEM II Albumin	77168	EUDAMED	IVD General	Active
GLUCOCARD S Control Solution	109217	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Panel-E	109214	EUDAMED	IVD General	Active
SPOTCHEM D Panel-D	109213	EUDAMED	IVD General	Active
Glucocard 01 Sensor	78610	EUDAMED	IVD Annex II List B	Active
Concentrated Washing Solution 3	108848	EUDAMED	Class A	Active
Osmo Station (om-6060)	60704	EUDAMED	IVD General	Active
Spotchem D-00 (sd-9810)	17402	EUDAMED	IVD General	Active
AUTION CHECK Plus	73527	EUDAMED	IVD General	Active
Spotchem Ii Stat-1	77418	EUDAMED	IVD General	Active
AUTION Sticks 10EA	73591	EUDAMED	IVD General	Active
SPOTCHEM II Heart-2	77421	EUDAMED	IVD General	Active
GLUCOCARD W Test Strips	108484	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Total Protein	77167	EUDAMED	IVD General	Active
AUTION SCREEN Microalbumin/Creatinine	73601	EUDAMED	IVD General	Active
Spotchem D Tc	77951	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	108493	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Blood Urea Nitrogen	77164	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	108985	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S onyx (GT-7120)	108481	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Total Bilirubin	77165	EUDAMED	IVD General	Active
Spotchem Ii Panel-V2	102728	EUDAMED	IVD General	Active
Glucocard W (gt-7210)	100816	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Test Strips	108496	EUDAMED	IVD Annex II List B	Active
Spotchem D Ip	77947	EUDAMED	IVD General	Active
Spotchem D-02 (sd-4810)	107504	EUDAMED	Class A	Active
Spotchem D Amy2	109082	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	109325	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Inorganic Phosphorus	77179	EUDAMED	IVD General	Active
Glucocard S	109574	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Magnesium	77180	EUDAMED	IVD General	Active
Spotchem D Tp	77953	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.