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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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467 device results listed.

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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-100528LK
Basic UDI-DI: B-100528LK
Reference: 100528
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100525LD
Basic UDI-DI: B-100525LD
Reference: 100525
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100477LT
Basic UDI-DI: B-100477LT
Reference: 100477
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100476LR
Basic UDI-DI: B-100476LR
Reference: 100476
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100475LP
Basic UDI-DI: B-100475LP
Reference: 100475
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

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SPOTCHEM II Amy-wide

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100170KW
Basic UDI-DI: B-100170KW
Reference: 100170
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Hungary
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem Printer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486037361
Basic UDI-DI: 4987486BC0107856HS
Reference: 107856
EMDN: W02079080
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION ELEVEN (AE-4020)

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033141
Basic UDI-DI: 4987486BC0107308GN
Reference: 107309
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION ELEVEN (AE-4020)

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033158
Basic UDI-DI: 4987486BC0107308GN
Reference: 107310
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

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PocketChem UA (PU-4010)

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033387
Basic UDI-DI: 4987486BC0107332GK
Reference: 107333
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033394
Basic UDI-DI: 4987486BC0107332GK
Reference: 107334
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486035992
Basic UDI-DI: 4987486BC0107664HF
Reference: 107665
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

Cuvette (heparin)

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039082
Basic UDI-DI: 4987486BC0108238GZ
Reference: 108239
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

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Whole Blood Sample Tube

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039112
Basic UDI-DI: 4987486BC0108241GN
Reference: 108242
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486040125
Basic UDI-DI: 4987486BC0107664HF
Reference: 108521
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Portugal
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486040132
Basic UDI-DI: 4987486BC0107664HF
Reference: 108522
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Portugal
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486040149
Basic UDI-DI: 4987486BC0107664HF
Reference: 108523
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486040156
Basic UDI-DI: 4987486BC0107664HF
Reference: 108524
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486040163
Basic UDI-DI: 4987486BC0107664HF
Reference: 108525
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class ANot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486040170
Basic UDI-DI: 4987486BC0107664HF
Reference: 108526
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.06.2026 15:16

Manufacturer products Authorised representative products Authorised representative actors View details