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LabPro Connect v5.0 System DVD Kit (FMR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C38722W7
Basic UDI-DI: B-C38722W7
Reference: C38722
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro v5.0 System DVD Kit (FMR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C38721W5
Basic UDI-DI: B-C38721W5
Reference: C38721
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro v5.0 HelpCenter Base Content

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C38653WD
Basic UDI-DI: B-C38653WD
Reference: C38653
EMDN: W0203010192
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro Connect v5.0 (FMR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C38651W9
Basic UDI-DI: B-C38651W9
Reference: C38651
EMDN: W0203010192
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro v5.0 (FMR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C38649WN
Basic UDI-DI: B-C38649WN
Reference: C38649
EMDN: W0203010192
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan MSF Neg/Pos ID Panel Type 2

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C38213VD
Basic UDI-DI: B-C38213VD
Reference: C38213
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxH 690T Coulter Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C34520UV
Basic UDI-DI: B-C34520UV
Reference: C34520
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: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan MSF FAST MIC Panel Type 2

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C32700UK
Basic UDI-DI: B-C32700UK
Reference: C32700
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan MSF Neg MIC Panel Type 2

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C32699VT
Basic UDI-DI: B-C32699VT
Reference: C32699
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan MSF Pos MIC Panel Type 2

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C32698VR
Basic UDI-DI: B-C32698VR
Reference: C32698
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan Neg Multidrug Resistant MIC 1

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C32368UZ
Basic UDI-DI: B-C32368UZ
Reference: C32368
EMDN: W0203010185
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

Labpro v5.0 System (MR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C24166UN
Basic UDI-DI: B-C24166UN
Reference: C24166
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro Connect v5.0 (MR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C24158UP
Basic UDI-DI: B-C24158UP
Reference: C24158
EMDN: W0203010192
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

LabPro v5.0 (MR)

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C24155UH
Basic UDI-DI: B-C24155UH
Reference: C24155
EMDN: W0203010192
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel® DxH 900 Coulter® Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C11478UC
Basic UDI-DI: B-C11478UC
Reference: C11478
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: 13.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER 6C Plus Cell Control

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C07297V5
Basic UDI-DI: B-C07297V5
Reference: C07297
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:50

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel® DxH 800 Coulter® Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B66445WA
Basic UDI-DI: B-B66445WA
Reference: B66445
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: 13.07.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c Reagent (HbA1c3 250)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B36415UY
Basic UDI-DI: B-B36415UY
Reference: B36415
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B24985VM
Basic UDI-DI: B-B24985VM
Reference: B24985
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxH 800 Coulter Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B24802UJ
Basic UDI-DI: B-B24802UJ
Reference: B24802
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: 12.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details