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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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Adams A1C Ⅹ (HA-8110)

IVD Class ANot specifiedNot intended for EU market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044161
Basic UDI-DI: 4987486BC0109334H5
Reference: 109334
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.09.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

COLUMN UNIT

IVD Class ANot specifiedNot intended for EU market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044185
Basic UDI-DI: 4987486BC0109337HB
Reference: 109337
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.09.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

COLUMN UNIT

IVD Class ANot specifiedNot intended for EU market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044628
Basic UDI-DI: 4987486BC0109337HB
Reference: 109511
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.09.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

DILUENT

IVD Class ANot specifiedNot intended for EU market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044239
Basic UDI-DI: 4987486BC0109342H4
Reference: 109342
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.09.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

WASHING SOLUTION W

IVD Class ANot specifiedNot intended for EU market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 14987486044229
Basic UDI-DI: 4987486BC0109341H2
Reference: 109341
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 22.09.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

SpotChem EL 2 (SE-1530)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486051367
Basic UDI-DI: 4987486BC0110048FD
Reference: 111113
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

SpotChem D-Concept 2e (SD-4840)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486047216
Basic UDI-DI: 4987486BC0110046F9
Reference: 110046
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

SpotChem D-Concept 2c (SD-4830)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486047186
Basic UDI-DI: 4987486BC0110044F5
Reference: 110044
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: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

WeCheck for S onyx

IVD Class AIVDR 2017/746On the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044604
Basic UDI-DI: 4987486BC0109504H6
Reference: 109504
EMDN: W020106019082
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolysis Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486043768
Basic UDI-DI: 4987486BC0109274HC
Reference: 109274
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

AutionIDaten (AE-4070)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039594
Basic UDI-DI: 4987486BC0108412GR
Reference: 108412
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Tube (for SPOTCHEM EZ)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039129
Basic UDI-DI: 4987486BC0108243GS
Reference: 108243
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Whole Blood Sample Tube

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039105
Basic UDI-DI: 4987486BC0108241GN
Reference: 108241
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Cup (for D-Concept)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039099
Basic UDI-DI: 4987486BC0108240GL
Reference: 108240
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Cuvette (heparin)

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039075
Basic UDI-DI: 4987486BC0108238GZ
Reference: 108238
EMDN: W050301029099
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 001 (CE-8810)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039044
Basic UDI-DI: 4987486BC0108223GL
Reference: 108223
EMDN: W020105010202
EMDN description: CAPILLARY ELECTROPHORESIS SYSTEMS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EL (SE-1520)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486038009
Basic UDI-DI: 4987486BC0107975J3
Reference: 107975
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem BA (PA-4140)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486036227
Basic UDI-DI: 4987486BC0107687HT
Reference: 107687
EMDN: W0201010203
EMDN description: BLOOD-AMMONIA CHECKERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION EYE Sheath Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486035985
Basic UDI-DI: 4987486BC0107664HF
Reference: 107664
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D-00 QR (SD-9811)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034605
Basic UDI-DI: 4987486BC0107507GW
Reference: 107507
EMDN: W0201030180
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details