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IMMAGE Immunochemistry Systems DIL 1 Diluent 1

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575335
Basic UDI-DI: 150995901447640LF
Reference: 447640
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems BUF 1 Buffer 1

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575328
Basic UDI-DI: 150995901447650LJ
Reference: 447650
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems BUF 2 Buffer 2

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575298
Basic UDI-DI: 150995901447040KH
Reference: 447040
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575137
Basic UDI-DI: 150995901465365LQ
Reference: 465365
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Belgium
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 2 Calibrator 2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232634
Basic UDI-DI: 150995901663940MJ
Reference: 663940
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

APO CAL Apolipoprotein Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232023
Basic UDI-DI: 150995901469283MH
Reference: 469283
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227043
Basic UDI-DI: 150995901474020KP
Reference: 474020
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

Access Sample Containers

81914

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223564
Basic UDI-DI: 15099590181914T9
Reference: 81914
EMDN: W05020180
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 3 Calibrator 3

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223250
Basic UDI-DI: 150995901449730LX
Reference: 449730
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223243
Basic UDI-DI: 150995901468429ME
Reference: 468429
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems UCAL Urine Protein Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590222673
Basic UDI-DI: 150995901441470K4
Reference: 441470
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:28

Manufacturer products Authorised representative products Authorised representative actors View details

CAL 5 PLUS Calibrator 5 Plus

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221256
Basic UDI-DI: 150995901469975NM
Reference: 469975
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 1 Calibrator 1

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590200060
Basic UDI-DI: 150995901449560LW
Reference: 449560
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

DxC 500 AU Module w/ ISE, DxC 500i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666545089
Basic UDI-DI: 150995901DxC500iRD
Reference: C63522
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: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

Optima XPN – 100K (IVD)

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590416324
Basic UDI-DI: 150995901OPTIMALK
Reference: A99846
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

CYTO-COMP Cells Kit

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590540371
Basic UDI-DI: 15099590LS-1-SetCmp-F7
Reference: 6607023
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590540425
Basic UDI-DI: 150995901LSMABEA
Reference: 6607013
EMDN: W0103080106
EMDN description: ANTIBODIES FOR LYMPHOCYTE SUBTYPING
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNO-TROL Cells

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590540449
Basic UDI-DI: 150995901LSIMMUNOTROLXV
Reference: 6607077
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER CYTO-TROL Control Cells Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590541972
Basic UDI-DI: 150995901LSIMMUNOTROLXV
Reference: 6604248
EMDN: W0103080403
EMDN description: LYMPHOCYTE SUBTYPING CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

Aliquot Tips, Case of 3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590590468
Basic UDI-DI: 150995901PEUA
Reference: 800257
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 29.06.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details