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457 device results listed.

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AUTION EYE (AI-4510)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106026LY
Basic UDI-DI: B-106026LY
Reference: 106026
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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GLUCOCARD S Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105902MQ
Basic UDI-DI: B-105902MQ
Reference: 105902
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Spain
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105885NH
Basic UDI-DI: B-105885NH
Reference: 105885
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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Lactate Pro 2 Test Strip

IVD self-testing devicesIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105883ND
Basic UDI-DI: B-105883ND
Reference: 105883
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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Lactate Pro 2 Test Strip

IVD self-testing devicesIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105882NB
Basic UDI-DI: B-105882NB
Reference: 105882
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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CALIBRATOR 90

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105730MK
Basic UDI-DI: B-105730MK
Reference: 105730
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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DILUENT 90

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105729N2
Basic UDI-DI: B-105729N2
Reference: 105729
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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HEMOLYSIS WASHING SOLUTION 90H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105728MY
Basic UDI-DI: B-105728MY
Reference: 105728
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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ELUENT 90CV-S

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105727MW
Basic UDI-DI: B-105727MW
Reference: 105727
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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ELUENT 90CV

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105726MU
Basic UDI-DI: B-105726MU
Reference: 105726
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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ELUENT 90B

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105725MS
Basic UDI-DI: B-105725MS
Reference: 105725
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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ELUENT 90A

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105724MQ
Basic UDI-DI: B-105724MQ
Reference: 105724
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

COLUMN UNIT 90

IVD generalIVDDOn the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105723MN
Basic UDI-DI: B-105723MN
Reference: 105723
EMDN: W0201050280
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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AUTION EYE Control Solution

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105638MW
Basic UDI-DI: B-105638MW
Reference: 105638
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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AUTION EYE Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105639MY
Basic UDI-DI: B-105639MY
Reference: 105639
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105582MU
Basic UDI-DI: B-105582MU
Reference: 105582
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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The Lab 004 (DB-3910)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105581MS
Basic UDI-DI: B-105581MS
Reference: 105581
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 CRE

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105587N6
Basic UDI-DI: B-105587N6
Reference: 105587
EMDN: W01010207
EMDN description: CREATININE
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S onyx (GT-7120)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105294ML
Basic UDI-DI: B-105294ML
Reference: 105294
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D-03 SET

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105289MT
Basic UDI-DI: B-105289MT
Reference: 105289
EMDN: W0201030180
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details