Manufacturer

Arkray

India, JapanLegal entities : ARKRAY Factory, Inc., ARKRAY Healthcare Pvt. Ltd.

Markets : Austria · Belgium · Czechia · Finland · France · Germany · Ireland · Italy · Lithuania · Poland · Romania · Slovenia · Spain · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 34 · class I, II · latest in 2024 · see on the FDA website

Public contracts won : Spain 1

EU representative : ARKRAY Europe, B.V. (Netherlands)

Website support_arkrayeurope@arkray.co.jp

23 categories, 56 models including 52 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
High performance liquid chromatography systems	W0201050201	ADAMS A1c (HA-8180)98/79 ADAMS A1c (HA-8180T)3 refs ADAMS A1c (HA-8180V)3 refs ADAMS A1c (HA-8190V)2 refs ADAMS A1c (HA-8380V)98/79 1 other ADAMS A1c Lite (HA-8380V)	A IVDR, 98/79	EUDAMED record Report an error
High performance liquid chromatography systems - hardware accessories	W0201050280	COLUMN UNIT 804 refs COLUMN UNIT 80T4 refs COLUMN UNIT 902 refs COLUMN UNIT-HSVI-TP98/79 COLUMN UNIT-HSVI-VP98/79	A IVDR, 98/79	EUDAMED record Report an error
Samples analyses, plastic containers - other	W050301029099	Centrifuge Cup (for D-Concept) Centrifuge Tube (for SPOTCHEM EZ) Cuvette (heparin)2 refs Whole Blood Sample Tube2 refs	A IVDR	EUDAMED record Report an error
Blood glucose meters	W0201060102	GLUCOCARD S (GT-7110)5 refs98/79 GLUCOCARD S onyx (GT-7120)6 refs98/79 GLUCOCARD W (GT-7210)7 refs98/79 GLUCOCARD SM (GT-7120)2 refs98/79 (no longer marketed) GLUCOCARD Vital (GT-1050)98/79 (no longer marketed) 2 others GLUCOCARD X-meter (GT-1910)98/79 (no longer marketed) GLUCOCARD X-mini plus (GT-1960)3 refs98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	SpotChem D-Concept 2c (SD-4830) SPOTCHEM EZ (SP-4430)3 refs The Lab 004 (DB-3910)	A IVDR, 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Crystal Crystal 58IC104-25, 58IC104-50 Crystal Dengue NS1	B, C IVDR	EUDAMED record Report an error
Mixed panel multiparameter analysers - low routine (throughput <= 800 test/h)	W0201030101	SPOTCHEM D-01 (SD-3810)2 refs SPOTCHEM D-02 (SD-4810)2 refs SPOTCHEM D-03 (SD-4820)2 refs	A IVDR, 98/79	EUDAMED record Report an error
Osmometers	W02079017	OSMO STATION (OM-6050)3 refs98/79 OSMO STATION (OM-6060)3 refs98/79 OSMO STATION 2 (OM-6070)98/79	– 98/79	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	AUTION ELEVEN (AE-4020)6 refs AutionIDaten (AE-4070)3 refs PocketChem UA (PU-4010)8 refs	A IVDR, 98/79	EUDAMED record Report an error
Automated urine analysers	W020101020103	AUTION MAX (AX-4030)3 refs98/79 AUTION MAX (AX-4060)3 refs98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Crystal 16IC101-50 Crystal® VC - O1	C IVDR	EUDAMED record Report an error
Ion selective electrolyte analysers	W0201040201	SPOTCHEM EL (SE-1520)4 refs SpotChem EL 2 (SE-1530)	A IVDR, 98/79	EUDAMED record Report an error
Mixed panel multiparameter analysers - hardware accessories	W0201030180	SPOTCHEM D-00 (SD-9810)98/79 SPOTCHEM D-00 QR (SD-9811)2 refs	A IVDR, 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - consumables	W02079085	Washing Solution (Concentrate)3 refs Washing Solution (Concentration)98/79	A IVDR, 98/79	EUDAMED record Report an error
Automated urine analysers - consumables	W020101020185	Concentrated Washing Solution 34 refs	A IVDR, 98/79	EUDAMED record Report an error
Blood-ammonia checkers	W0201010203	PocketChem BA (PA-4140)3 refs	A IVDR, 98/79	EUDAMED record Report an error
Capillary electrophoresis systems	W020105010202	The Lab 001 (CE-8810)2 refs	A IVDR, 98/79	EUDAMED record Report an error
Chemistry analysers - low routine (with ise mode test/h <= 400)	W0201010105	SpotChem D-Concept 2e (SD-4840)	A IVDR	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	PARAHIT-F VER. 1.0 Rapid Test for P. falciparum Malaria Device	C IVDR	EUDAMED record Report an error
Urinary sediment devices	W0201010202	AUTION EYE (AI-4510)98/79	– 98/79	EUDAMED record Report an error
Various diabetes monitoring instruments - software accessories	W020106019082	WeCheck for S onyx	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - hardware accessories	W02079080	PocketChem Printer	A IVDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - hardware accessories	W0201069080	Lactate Pro 2 (LT-1730)2 refs98/79	– 98/79	EUDAMED record Report an error

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