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

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Early Sepsis Indicator Application (ESId)

C23700

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590706852
Basic UDI-DI: B-15099590706852
Reference: C23700
EMDN: W0202010192
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.10.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan HighFlexX Software v2.9.2

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590799649
Basic UDI-DI: 15099501MCHFLXG9
Reference: D23504
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.10.2026 13:43

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ASO Anti-Streptolysin O Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221188
Basic UDI-DI: 150995901447620L9
Reference: 447620
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233242
Basic UDI-DI: 150995901447480LH
Reference: 447480
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems High Sensitivity C-Reactive Protein (CRPH) Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227005
Basic UDI-DI: 150995901474630LQ
Reference: 474630
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter DxH Slides

B01276

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590209636
Basic UDI-DI: 150995901HEMACCESSORYP8
Reference: B01276
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Austria
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 21.09.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter DxH Slides

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590798215
Basic UDI-DI: 150995901HEMACCESSORYP8
Reference: D20332
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 21.09.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

Access BNP II

D06227

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590805678
Basic UDI-DI: 150995901BNPIIBE
Reference: D24688
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Quick Comp 4 Kit

CYTO-COMP Cell Kit

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232931
Basic UDI-DI: 15099590LS-1-SetCmp-F7
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: 30.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

Optima XPN – 90K (IVD)

Optima X series centrifuge

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590415754
Basic UDI-DI: 150995901OPTIMALK
Reference: A99842
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest CD8-PC7

Monoclonal Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590391522
Basic UDI-DI: 150995901LSANTIBODYREAQ2
Reference: 737661
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

IOTest MsIgG1-PC7

Isotypic Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590391515
Basic UDI-DI: 150995901ControlVQ
Reference: 737662
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

AutoMate 2500 Family

AutoMate 1200, AutoMate 1250, AutoMate 2500, AutoMate 2550

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590364106
Basic UDI-DI: 150995901ATMJ8
Reference: ODL25120, ODL25125, ODL25250, ODL25255
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE 800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265403
Basic UDI-DI: 150995901A15445PU
Reference: A15445
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access 2 Immunoassay System

81600N

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265380
Basic UDI-DI: 150995901Acc2FR
Reference: 81600N
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265373
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: 973100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Iso Flow Sheath (10L)

Iso Flow Sheath

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590250935
Basic UDI-DI: 150995901LSSHEATH9Z
Reference: 8546859
EMDN: W0103080699
EMDN description: REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Flow Check Fluorospheres

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233891
Basic UDI-DI: 150995901FLUOROSPHERES6B
Reference: 6605359
EMDN: W0103080401
EMDN description: SETUP BEADS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter Sample Cup 0.5 mL

651412

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233815
Basic UDI-DI: 150995901651412KT
Reference: 651412
EMDN: W05020180
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

628026

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233761
Basic UDI-DI: 150995901HEMCALIBRATORQQ
Reference: 628026
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details