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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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Access CEA Diluent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33206FS
Basic UDI-DI: B-33206FS
Reference: 33206
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33205FQ
Basic UDI-DI: B-33205FQ
Reference: 33205
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33200FE
Basic UDI-DI: B-33200FE
Reference: 33200
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER S-CAL Calibrator Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-179310Q2
Basic UDI-DI: B-179310Q2
Reference: 179310
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

QuickComp 2 Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-177018PM
Basic UDI-DI: B-177018PM
Reference: 177018
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

QuickComp 4 Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-177017PK
Basic UDI-DI: B-177017PK
Reference: 177017
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Leuko-Trol RBC Control Cells

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175658QH
Basic UDI-DI: B-175658QH
Reference: 175658
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Leuko-Trol Platelet Control Cells

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175651Q3
Basic UDI-DI: B-175651Q3
Reference: 175651
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER AcT 5diff Autoloader Hematology Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175356PW
Basic UDI-DI: B-175356PW
Reference: 175356
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter DxH Cell Lyse

IVD Class ANot specifiedOn the marketReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233709
Basic UDI-DI: 150995901HEMLYSEQK
Reference: 628019
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cleaner

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233747
Basic UDI-DI: 150995901HEMCLEANERXZ
Reference: 628023
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233778
Basic UDI-DI: 150995901HEMCONTROL9R
Reference: 628027
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233785
Basic UDI-DI: 150995901HEMCONTROL9R
Reference: 628028
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233808
Basic UDI-DI: 150995901HEMCONTROL9R
Reference: 628030
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter Sample Cup 2 mL

IVD Class ANot specifiedOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233853
Basic UDI-DI: 15099590181902T2
Reference: 652730
EMDN: W05020180
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 600 Access Immunoassay System

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590341602
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A30260
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590369194
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A71456
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 600 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590369224
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: A71460
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest CD4-PC7

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590391539
Basic UDI-DI: 150995901LSANTIBODYREAQ2
Reference: 737660
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

CD8-ECD

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590391546
Basic UDI-DI: 150995901LSANTIBODYREAQ2
Reference: 737659
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details