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HAV Ab QC

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34209G7
Basic UDI-DI: B-34209G7
Reference: 34209
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 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34205FX
Basic UDI-DI: B-34205FX
Reference: 34205
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 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab (Reagent pack)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34200FM
Basic UDI-DI: B-34200FM
Reference: 34200
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access Digoxin Calibrator S0

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33716GN
Basic UDI-DI: B-33716GN
Reference: 33716
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - 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 Digoxin Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33715GL
Basic UDI-DI: B-33715GL
Reference: 33715
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - 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 Digoxin (reagent pack)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33710GA
Basic UDI-DI: B-33710GA
Reference: 33710
EMDN: W0102080101
EMDN description: DIGOXIN
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 QC

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33209FY
Basic UDI-DI: B-33209FY
Reference: 33209
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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 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 AIVDR 2017/746On 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 AIVDR 2017/746On 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 CIVDR 2017/746On 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 CIVDR 2017/746On 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