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

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Total Protein Reagent (TP 2 x 300)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442740PL
Basic UDI-DI: B-442740PL
Reference: 442740
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Phosphatase Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442670PQ
Basic UDI-DI: B-442670PQ
Reference: 442670
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Aspartate Aminotransferase Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442665PX
Basic UDI-DI: B-442665PX
Reference: 442665
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Lactate Dehydrogenase Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442655PU
Basic UDI-DI: B-442655PU
Reference: 442655
EMDN: W01010120
EMDN description: LACTATE DEHYDROGENASE P ( LDH - P --> L )
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Lactate Dehydrogenase Reagent (LD-P 2 x 200)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442660PM
Basic UDI-DI: B-442660PM
Reference: 442660
EMDN: W01010120
EMDN description: LACTATE DEHYDROGENASE P ( LDH - P --> L )
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442635PN
Basic UDI-DI: B-442635PN
Reference: 442635
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma-Glutamyl Transferase Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442650PJ
Basic UDI-DI: B-442650PJ
Reference: 442650
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Alanine Aminotransferase Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442620P9
Basic UDI-DI: B-442620P9
Reference: 442620
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON® Systems SYNCHRON Multi Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-442600P3
Basic UDI-DI: B-442600P3
Reference: 442600
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems UCAL Urine Protein Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-441470P7
Basic UDI-DI: B-441470P7
Reference: 441470
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 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-441350NU
Basic UDI-DI: B-441350NU
Reference: 441350
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Direct Bilirubin Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-439715QT
Basic UDI-DI: B-439715QT
Reference: 439715
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Ammonia Reagent (AMM 2 x 25)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-439770R3
Basic UDI-DI: B-439770R3
Reference: 439770
EMDN: W01010301
EMDN description: AMMONIA
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Salicylate Reagent (SALY 2 x 45)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-378194RB
Basic UDI-DI: B-378194RB
Reference: 378194
EMDN: W0102090213
EMDN description: SALICYLATE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Vancomycin Calibrator

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-378045QR
Basic UDI-DI: B-378045QR
Reference: 378045
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-378020Q9
Basic UDI-DI: B-378020Q9
Reference: 378020
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 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34479H6
Basic UDI-DI: B-34479H6
Reference: 34479
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34475GW
Basic UDI-DI: B-34475GW
Reference: 34475
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 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34470GL
Basic UDI-DI: B-34470GL
Reference: 34470
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access RUBELLA IgM QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34449GV
Basic UDI-DI: B-34449GV
Reference: 34449
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details