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IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590781521
Basic UDI-DI: 150995901AccCKMBXX
Reference: D00534
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan LabPro v5 EU SMU Predictive Susceptibility (MR), Electronic

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590782559
Basic UDI-DI: 15099501MCSWMN
Reference: D03455
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan LabPro v5.00 Data Delivery-03, Electronic

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590785000
Basic UDI-DI: 15099501MCSWMN
Reference: D05946
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter Flow cytometer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000011854
UDI-DI: 15099590787646
Basic UDI-DI: 150995907DxFLEXVE
Reference: D08965
EMDN: W0202040180
EMDN description: CYTOFLOWMETERS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

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Beckman Coulter Flow cytometer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000011854
UDI-DI: 15099590787707
Basic UDI-DI: 150995907DxFLEXVE
Reference: D08973
EMDN: W0202040180
EMDN description: CYTOFLOWMETERS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan LabPro v5.00 Data Delivery-05, MR, Electronic

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590789299
Basic UDI-DI: 15099501MCSWMN
Reference: D11977
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590792930
Basic UDI-DI: 15099501MCSWMN
Reference: D12429
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

MicroScan LabPro V4_V5 Maintenance Update 05 (MR,FMR), Electronic

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590793012
Basic UDI-DI: 15099501MCSWMN
Reference: D12596
EMDN: W0203010182
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

DxH

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: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

15099590802110

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590802110
Basic UDI-DI: 150995901CellMekH8
Reference: D27513
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:40

Manufacturer products Authorised representative products Authorised representative actors View details

CHEMISTRY ANALYZER DxC 700 AU for Direct Track Sampling

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542507
Basic UDI-DI: 150995901DxC700AU2E
Reference: B86445
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 26.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

CHEMISTRY ANALYZER DxC 700 AU for Direct Track Sampling with ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542514
Basic UDI-DI: 150995901DxC700AU2E
Reference: B86446
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 26.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

CHEMISTRY ANALYZER DxC 700 AU with ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542545
Basic UDI-DI: 150995901DxC700AU2E
Reference: B86444
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 19.06.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU480 with ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542972
Basic UDI-DI: 150995901AU4805D
Reference: B96693
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 19.06.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU680 for Direct Track Sampling with ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666542996
Basic UDI-DI: 150995901AU6805P
Reference: B96695
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 19.06.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU680 with ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666543009
Basic UDI-DI: 150995901AU6805P
Reference: B96696
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 19.06.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter CHEMISTRY ANALYZER AU5800, Automation Ready

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666543023
Basic UDI-DI: 150995901AU58003W
Reference: B96698
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 19.06.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

DxC 500 AU Clinical Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666545065
Basic UDI-DI: 150995901DxC500AUZM
Reference: C63520
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 19.06.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER AcT 5diff Autoloader Hematology Analyzer

IVD generalNot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175356PW
Basic UDI-DI: B-175356PW
Reference: 175356
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 16.06.2026 02:46

Manufacturer products Authorised representative products Authorised representative actors View details

Leuko-Trol Platelet Control Cells

IVD generalNot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175651Q3
Basic UDI-DI: B-175651Q3
Reference: 175651
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 16.06.2026 02:46

Manufacturer products Authorised representative products Authorised representative actors View details