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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 AFP

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817930
Basic UDI-DI: 150995909AccAFP300WZ
Reference: C28649
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:14

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Access Hybritech PSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817886
Basic UDI-DI: 150995909AccHPSA76
Reference: C22845
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:14

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UniCel DxI 800 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817633
Basic UDI-DI: 150995909UniCelDxIG9
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: 22.09.2026 01:14

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UniCel DxI 600 Access Immunoassay System

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817497
Basic UDI-DI: 150995909UniCelDxIG9
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: 22.09.2026 01:14

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UniCel DxI 600 Access Immunoassay System w/Spot B

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817640
Basic UDI-DI: 150995909UniCelDxIG9
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: 22.09.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

Access 2 mL Sample Cups/

IVD Class AIVDR 2017/746On the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817152
Basic UDI-DI: 15099590981902WA
Reference: 81902
EMDN: W05020180
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:14

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DxC 500 AU Module, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818234
Basic UDI-DI: 150995909DxC500iW5
Reference: C63521
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 00:51

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DxC 500 AU Module w/ ISE, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818241
Basic UDI-DI: 150995909DxC500iW5
Reference: C63522
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 00:50

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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