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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 2 of 7

Device	Model / Reference	Registries	Class	Status
AUTION Sticks 10V	102595	EUDAMED	IVD General	Active
Column Unit-Hsvi-Vp	71193	EUDAMED	IVD General	Active
GLUCOCARD S Control Solution	108501	EUDAMED	IVD Annex II List B	Active
Spotchem D Tg	77952	EUDAMED	IVD General	Active
Washing Solution (Concentrate)	109112	EUDAMED	Class A	Active
Spotchem Calibrator Kit	77041I	EUDAMED	IVD General	Active
AUTION Sticks 10PA	73524	EUDAMED	IVD General	Active
AUTION Control Solution	73806	EUDAMED	IVD General	Active
ADAMS A1c (HA-8180T)	34114	EUDAMED	IVD General	Active
SPOTCHEM D Panel-C	109212	EUDAMED	IVD General	Active
Hemolysis Solution	109274	EUDAMED	Class A	Active
Spotchem D Hdl	77946	EUDAMED	IVD General	Active
Whole Blood Sample Tube	108241	EUDAMED	Class A	Active
GLUCOCARD S Control Solution	108500	EUDAMED	IVD Annex II List B	Active
OSMO STATION Control Solution Set	106342	EUDAMED	IVD General	Active
AUTION EYE Sheath Solution	108521	EUDAMED	Class A	Active
GLUCOCARD G sensor	77743	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Control Solution	108498	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Screening	105107	EUDAMED	IVD General	Active
AutionIDaten (AE-4070)	108203	EUDAMED	IVD General	Active
Uriflet S 9HA	73521	EUDAMED	IVD General	Active
Eluent 80cv	42510	EUDAMED	IVD General	Active
Eluent 80b	71275	EUDAMED	IVD General	Active
Spotchem Ii Cpk	77407	EUDAMED	IVD General	Active
AUTION Sheath Solution	73811	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	103462	EUDAMED	IVD Annex II List B	Active
Column Unit 80t	107363	EUDAMED	Class A	Active
Diluent 90	107375	EUDAMED	Class A	Active
Standard Solution Set	70305	EUDAMED	IVD General	Active
Spotchem El (se-1520)	47204	EUDAMED	IVD General	Active
Glucocard Sm Test Strips	47389	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Total-A2	102733	EUDAMED	IVD General	Active
GLUCOCARD X-meter (GT-1910)	47546	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Stat2	102732	EUDAMED	IVD General	Active
Washing Solution (Concentrate)	107295	EUDAMED	Class A	Active
Uriflet S 10HA	73519	EUDAMED	IVD General	Active
PocketChem BA (PA-4140)	20503	EUDAMED	IVD General	Active
SPOTCHEM II Triglyceride	77163	EUDAMED	IVD General	Active
ADAMS A1c Lite (HA-8380V)	107377	EUDAMED	Class A	Active
GLUCOCARD X-mini plus (GT-1960)	46746	EUDAMED	IVD Annex II List B	Active
Uriflet S 11UA	102747	EUDAMED	IVD General	Active
CALIBRATOR Lite	101714	EUDAMED	IVD General	Active
Osmo Station (om-6050)	60504	EUDAMED	IVD General	Active
Glucocard 01 Control	78548	EUDAMED	IVD Annex II List B	Active
Spotchem D Ua	77954	EUDAMED	IVD General	Active
SPOTCHEM II Liver-1	77417	EUDAMED	IVD General	Active
GLUCOCARD W Test Strips	104951	EUDAMED	IVD Annex II List B	Active
GLUCOCARD X-mini plus (GT-1960)	100476	EUDAMED	IVD Annex II List B	Active
GLUCOCARD X-sensor	78727	EUDAMED	IVD Annex II List B	Active
Glucocard W (gt-7210)	100820	EUDAMED	IVD Annex II List B	Active

Related Companies

Authorised Representatives

ARKRAY Europe, B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.