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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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467 device results listed.

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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

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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

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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

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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

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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

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SPOTCHEM D-02 SET

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105287MP
Basic UDI-DI: B-105287MP
Reference: 105287
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

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SPOTCHEM D-01 SET

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105285MK
Basic UDI-DI: B-105285MK
Reference: 105285
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

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SPOTCHEM D Screening

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105107LS
Basic UDI-DI: B-105107LS
Reference: 105107
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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SPOTCHEM D Liver-D

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105105LN
Basic UDI-DI: B-105105LN
Reference: 105105
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104953N2
Basic UDI-DI: B-104953N2
Reference: 104953
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104952MY
Basic UDI-DI: B-104952MY
Reference: 104952
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104951MW
Basic UDI-DI: B-104951MW
Reference: 104951
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

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SPOTCHEM D-00 QR (SD-9811)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104933MU
Basic UDI-DI: B-104933MU
Reference: 104933
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

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104861MU
Basic UDI-DI: B-104861MU
Reference: 104861
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
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-104166M3
Basic UDI-DI: B-104166M3
Reference: 104166
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

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GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-103716MB
Basic UDI-DI: B-103716MB
Reference: 103716
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-103715M9
Basic UDI-DI: B-103715M9
Reference: 103715
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-103714M7
Basic UDI-DI: B-103714M7
Reference: 103714
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-103711LZ
Basic UDI-DI: B-103711LZ
Reference: 103711
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details