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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Hemoglobin A1c- Reagent (HbA1c-400)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A87905X7
Basic UDI-DI: B-A87905X7
Reference: A87905
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Amylase Reagent (AMY7 2 x 200)

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A71607V7
Basic UDI-DI: B-A71607V7
Reference: A71607
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Enzymatic Creatinine Reagent (CR-E 2 x 200)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A60298UW
Basic UDI-DI: B-A60298UW
Reference: A60298
EMDN: W01010207
EMDN description: CREATININE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

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-A59925WS
Basic UDI-DI: B-A59925WS
Reference: A59925
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Creatinine Reagent (CR-S 2 x 300)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40920U6
Basic UDI-DI: B-A40920U6
Reference: A40920
EMDN: W01010207
EMDN description: CREATININE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgM QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40707U4
Basic UDI-DI: B-A40707U4
Reference: A40707
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgM, Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40706U2
Basic UDI-DI: B-A40706U2
Reference: A40706
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40705TY
Basic UDI-DI: B-A40705TY
Reference: A40705
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgG QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40704TW
Basic UDI-DI: B-A40704TW
Reference: A40704
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgG Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40703TU
Basic UDI-DI: B-A40703TU
Reference: A40703
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40702TS
Basic UDI-DI: B-A40702TS
Reference: A40702
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A38656VR
Basic UDI-DI: B-A38656VR
Reference: A38656
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Rubella IgM

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A32937US
Basic UDI-DI: B-A32937US
Reference: A32937
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgG QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A31590U3
Basic UDI-DI: B-A31590U3
Reference: A31590
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgG Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A31589UJ
Basic UDI-DI: B-A31589UJ
Reference: A31589
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgG

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A31588UG
Basic UDI-DI: B-A31588UG
Reference: A31588
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems ISE Electrolyte Buffer Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A28945VQ
Basic UDI-DI: B-A28945VQ
Reference: A28945
EMDN: W01010399
EMDN description: ELECTROLYTES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ab QC

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24298UE
Basic UDI-DI: B-A24298UE
Reference: A24298
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems ISE Electrolyte Reference Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A28937VR
Basic UDI-DI: B-A28937VR
Reference: A28937
EMDN: W01010399
EMDN description: ELECTROLYTES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ab Calibrators

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24297UC
Basic UDI-DI: B-A24297UC
Reference: A24297
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details