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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 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: -
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 02.07.2026 01:04

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: -
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: 02.07.2026 01:04

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: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 02.07.2026 01:03

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: -
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
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

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: -
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: 02.07.2026 01:03

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: -
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge Tube (for SPOTCHEM EZ)

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039129
Basic UDI-DI: 4987486BC0108243GS
Reference: 108243
EMDN: -
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
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

Whole Blood Sample Tube

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039105
Basic UDI-DI: 4987486BC0108241GN
Reference: 108241
EMDN: -
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
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

Centrifuge Cup (for D-Concept)

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039099
Basic UDI-DI: 4987486BC0108240GL
Reference: 108240
EMDN: -
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
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

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

Cuvette (heparin)

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486039075
Basic UDI-DI: 4987486BC0108238GZ
Reference: 108238
EMDN: -
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER
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

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: -
EMDN description: CAPILLARY ELECTROPHORESIS SYSTEMS
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

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: -
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
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

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: -
EMDN description: BLOOD-AMMONIA CHECKERS
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 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: -
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
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

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: -
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - 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

SPOTCHEM D-03 (SD-4820)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034582
Basic UDI-DI: 4987486BC0107505GS
Reference: 107505
EMDN: -
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
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

SPOTCHEM D-02 (SD-4810)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034575
Basic UDI-DI: 4987486BC0107504GQ
Reference: 107504
EMDN: -
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
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

SPOTCHEM D-01 (SD-3810)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034568
Basic UDI-DI: 4987486BC0107503GN
Reference: 107503
EMDN: -
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
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

SPOTCHEM EZ (SP-4430)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034551
Basic UDI-DI: 4987486BC0107501GJ
Reference: 107501
EMDN: -
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: 02.07.2026 01:03

Manufacturer products Authorised representative products Authorised representative actors View details