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UniCel® DxH 800 Coulter® Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-629029QJ
Basic UDI-DI: B-629029QJ
Reference: 629029
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: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER Body Fluid Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628030PU
Basic UDI-DI: B-628030PU
Reference: 628030
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER LIN-X Linearity Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628029QB
Basic UDI-DI: B-628029QB
Reference: 628029
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER Retic-X Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628028Q9
Basic UDI-DI: B-628028Q9
Reference: 628028
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER 6C Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628027Q7
Basic UDI-DI: B-628027Q7
Reference: 628027
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

S-CAL Calibrator

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628026Q5
Basic UDI-DI: B-628026Q5
Reference: 628026
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER Latron CP-X Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628024PZ
Basic UDI-DI: B-628024PZ
Reference: 628024
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter Retic-C Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-624671QC
Basic UDI-DI: B-624671QC
Reference: 624671
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:38

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-624519Q5
Basic UDI-DI: B-624519Q5
Reference: 624519
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter 5C Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-624506PU
Basic UDI-DI: B-624506PU
Reference: 624506
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNummber447460R4
Basic UDI-DI: B-PartNummber447460R4
Reference: 447460
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE UDR Kit (1-pack)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartnumberA097916X
Basic UDI-DI: B-PartnumberA097916X
Reference: A09791
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Neg Combo 96

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumberC79388AK
Basic UDI-DI: B-PartNumberC79388AK
Reference: C79388
EMDN: W0104080101
EMDN description: GRAM NEGATIVE IDENTIFICATION - AUTOMATED
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Neg Combo 94

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumberC637278W
Basic UDI-DI: B-PartNumberC637278W
Reference: C63727
EMDN: W0104080101
EMDN description: GRAM NEGATIVE IDENTIFICATION - AUTOMATED
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro Connect v5.0 System (MR)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumberC2416777
Basic UDI-DI: B-PartNumberC2416777
Reference: C24167
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Pos Combo Panel Type 31

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumberB1016-139XT
Basic UDI-DI: B-PartNumberB1016-139XT
Reference: B1016-139
EMDN: W0203010192
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER CLONE MY4-RD1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumber6603262SL
Basic UDI-DI: B-PartNumber6603262SL
Reference: 6603262
EMDN: W0103080199
EMDN description: MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

LeukoSure Enumeration Kit

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartNumber17562129
Basic UDI-DI: B-PartNumber17562129
Reference: 175621
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Pos Combo Panel Type 49

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C80309VS
Basic UDI-DI: B-C80309VS
Reference: C80309
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Pos Combo Panel Type 48

IVD generalIVDDOn the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C80308VQ
Basic UDI-DI: B-C80308VQ
Reference: C80308
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details