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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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Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465365QT
Basic UDI-DI: B-465365QT
Reference: 465365
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 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems Level 2 Urine Protein Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465300PX
Basic UDI-DI: B-465300PX
Reference: 465300
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems Level 1 Urine Protein Control

IVD generalIVDDOn the marketHuman tissuesReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465290QM
Basic UDI-DI: B-465290QM
Reference: 465290
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Reagent (CRP 2 x 200)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465131PY
Basic UDI-DI: B-465131PY
Reference: 465131
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 20 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-464390QK
Basic UDI-DI: B-464390QK
Reference: 464390
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 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Protein Calibrator Levels 1 and 2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450202NG
Basic UDI-DI: B-450202NG
Reference: 450202
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 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450164NZ
Basic UDI-DI: B-450164NZ
Reference: 450164
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450163NX
Basic UDI-DI: B-450163NX
Reference: 450163
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450162NV
Basic UDI-DI: B-450162NV
Reference: 450162
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450130NG
Basic UDI-DI: B-450130NG
Reference: 450130
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450125NP
Basic UDI-DI: B-450125NP
Reference: 450125
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450120ND
Basic UDI-DI: B-450120ND
Reference: 450120
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 3 Calibrator 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-449730R2
Basic UDI-DI: B-449730R2
Reference: 449730
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 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 1 Calibrator 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-449560QZ
Basic UDI-DI: B-449560QZ
Reference: 449560
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 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447790R6
Basic UDI-DI: B-447790R6
Reference: 447790
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447750QS
Basic UDI-DI: B-447750QS
Reference: 447750
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447740QP
Basic UDI-DI: B-447740QP
Reference: 447740
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447780R3
Basic UDI-DI: B-447780R3
Reference: 447780
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447760QV
Basic UDI-DI: B-447760QV
Reference: 447760
EMDN: W0102010299
EMDN description: COMPLEMENT COMPONENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447730QL
Basic UDI-DI: B-447730QL
Reference: 447730
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details