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EUDAMED Device Search

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

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457 device results listed.

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SPOTCHEM II Uric Acid

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77161J5
Basic UDI-DI: B-77161J5
Reference: 77161
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Glucose

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77160J3
Basic UDI-DI: B-77160J3
Reference: 77160
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM E-Plate

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77083JA
Basic UDI-DI: B-77083JA
Reference: 77083
EMDN: W01010803
EMDN description: MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM CALIBRATION CHECK

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77043HW
Basic UDI-DI: B-77043HW
Reference: 77043
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

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SPOTCHEM CALIBRATOR KIT

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77041IS6
Basic UDI-DI: B-77041IS6
Reference: 77041I
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

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AMMONIA TEST KIT II

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-75304HM
Basic UDI-DI: B-75304HM
Reference: 75304
EMDN: W01010301
EMDN description: AMMONIA
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:09

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AUTION Sheath Solution

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73811HV
Basic UDI-DI: B-73811HV
Reference: 73811
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION Staining Solution (BAC)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73810HT
Basic UDI-DI: B-73810HT
Reference: 73810
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION Staining Solution (SED)

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73809JA
Basic UDI-DI: B-73809JA
Reference: 73809
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION Diluent (BAC)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73808J8
Basic UDI-DI: B-73808J8
Reference: 73808
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION Diluent (SED)

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73807J6
Basic UDI-DI: B-73807J6
Reference: 73807
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION Control Solution

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73806J4
Basic UDI-DI: B-73806J4
Reference: 73806
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION Sticks 10PA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73621HN
Basic UDI-DI: B-73621HN
Reference: 73621
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:07

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AUTION SCREEN Microalbumin/Creatinine

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73601HG
Basic UDI-DI: B-73601HG
Reference: 73601
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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Uriflet S 9UB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73597JJ
Basic UDI-DI: B-73597JJ
Reference: 73597
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION Sticks 10EA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73594JC
Basic UDI-DI: B-73594JC
Reference: 73594
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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AUTION Sticks 10EA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73591J6
Basic UDI-DI: B-73591J6
Reference: 73591
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION CHECK Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73527HV
Basic UDI-DI: B-73527HV
Reference: 73527
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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AUTION Sticks 10PA

IVD generalIVDDNo longer on the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73524HP
Basic UDI-DI: B-73524HP
Reference: 73524
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 9HA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73521HH
Basic UDI-DI: B-73521HH
Reference: 73521
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details