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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 4 of 7

Device	Model / Reference	Registries	Class	Status
Uriflet S 9UB	101457	EUDAMED	IVD General	Active
SpotChem EL 2 (SE-1530)	111113	EUDAMED	Class A	Active
Glucocard 01 Control	78547	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Test Strips	107828	EUDAMED	IVD Annex II List B	Active
The Lab 001 A1C HD	106549	EUDAMED	IVD General	Active
The Lab 004 AST (GOT)	106406	EUDAMED	IVD General	Active
Spotchem Ii Stat-1	77183	EUDAMED	IVD General	Active
Spotchem D-02 (sd-4810)	17603	EUDAMED	IVD General	Active
Spotchem D Alp	77935	EUDAMED	IVD General	Active
GLUCOCARD X-mini plus (GT-1960)	46706	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Panel-V2	102734	EUDAMED	IVD General	Active
GLUCOCARD S onyx (GT-7120)	109316	EUDAMED	IVD Annex II List B	Active
Spotchem D-02 Set	105287	EUDAMED	IVD General	Active
GLUCOCARD G sensor	77734	EUDAMED	IVD Annex II List B	Active
Osmo Station (om-6050)	60505	EUDAMED	IVD General	Active
GLUCOCARD X-mini plus (GT-1960)	46748	EUDAMED	IVD Annex II List B	Active
The Lab 004 Ca	106334	EUDAMED	IVD General	Active
SPOTCHEM II Blood Urea Nitrogen	77399	EUDAMED	IVD General	Active
Spotchem D-00 Qr (sd-9811)	104933	EUDAMED	IVD General	Active
Spotchem D T-Bil	77950	EUDAMED	IVD General	Active
Spotchem D Ck	77940	EUDAMED	IVD General	Active
GLUCOCARD S Test Strips	101414	EUDAMED	IVD Annex II List B	Active
SPOTCHEM D Calibrator Kit	77964	EUDAMED	IVD General	Active
Eluent 90cv-S	105727	EUDAMED	IVD General	Active
The Lab 004 UA	106333	EUDAMED	IVD General	Active
SPOTCHEM II Creatinine2	102726	EUDAMED	IVD General	Active
GLUCOCARD X-mini plus (GT-1960)	46707	EUDAMED	IVD Annex II List B	Active
Lactate Pro 2 Test Strip	105882	EUDAMED	IVD devices for self-testing	Active
ADAMS A1c (HA-8190V)	107366	EUDAMED	Class A	Active
Glucocard W (gt-7210)	104953	EUDAMED	IVD Annex II List B	Active
Column Unit 80	107345	EUDAMED	Class A	Active
Uriflet S 9UB	23905	EUDAMED	IVD General	Active
Glucocard W (gt-7210)	109053	EUDAMED	IVD Annex II List B	Active
GLUCOCARD S Control Solution	109218	EUDAMED	IVD Annex II List B	Active
Aution Eye (ai-4510)	106026	EUDAMED	IVD General	Active
The Lab 004 (DB-3910)	105581	EUDAMED	Class A	Active
SPOTCHEM II Creatinine	77177	EUDAMED	IVD General	Active
Spotchem D Cre2	102729	EUDAMED	IVD General	Active
Uriflet S 10HB	73520	EUDAMED	IVD General	Active
Column Unit-Hsvi-Tp	71194	EUDAMED	IVD General	Active
AUTION Diluent (BAC)	73808	EUDAMED	IVD General	Active
SPOTCHEM II HDL-Cholesterol (Direct Method)	77181	EUDAMED	IVD General	Active
Aution Max (ax-4030)	102674	EUDAMED	IVD General	Active
ADAMS A1c (HA-8180T)	107361	EUDAMED	Class A	Active
Spotchem Ii Gpt/Alt	77405	EUDAMED	IVD General	Active
Spotchem D-03 (sd-4820)	107505	EUDAMED	Class A	Active
SPOTCHEM II Uric Acid	77396	EUDAMED	IVD General	Active
Diluent 90	105729	EUDAMED	IVD General	Active
Glucocard S (gt-7110)	108476	EUDAMED	IVD Annex II List B	Active
SPOTCHEM II Albumin	77403	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.