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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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IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474620QQ
Basic UDI-DI: B-474620QQ
Reference: 474620
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474020PS
Basic UDI-DI: B-474020PS
Reference: 474020
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 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Creatinine (CREm) Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472525QF
Basic UDI-DI: B-472525QF
Reference: 472525
EMDN: W01010207
EMDN description: CREATININE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems CO2 Alkaline Buffer

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472515QC
Basic UDI-DI: B-472515QC
Reference: 472515
EMDN: W01010302
EMDN description: BICARBONATE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON LX/DxC Blood Urea Nitrogen (BUNm)

SYNCHRON Systems Urea Nitrogen (BUN) Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472482QN
Basic UDI-DI: B-472482QN
Reference: 472482
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Glucose Reagent (Glucose Oxidase)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472500PX
Basic UDI-DI: B-472500PX
Reference: 472500
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

VigilTM TDM Control level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472472QK
Basic UDI-DI: B-472472QK
Reference: 472472
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON LX/DxC CO2 Acid Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472481QL
Basic UDI-DI: B-472481QL
Reference: 472481
EMDN: W01010302
EMDN description: BICARBONATE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

VigilTM TDM Control level 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472467QS
Basic UDI-DI: B-472467QS
Reference: 472467
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

VigilTM TDM Control level 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472461QE
Basic UDI-DI: B-472461QE
Reference: 472461
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Acetaminophen Reagent (ACTM 100)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472169QF
Basic UDI-DI: B-472169QF
Reference: 472169
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON and AU Systems Hemolyzing Reagent

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472137Q2
Basic UDI-DI: B-472137Q2
Reference: 472137
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 40 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472110PE
Basic UDI-DI: B-472110PE
Reference: 472110
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 10 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472107PR
Basic UDI-DI: B-472107PR
Reference: 472107
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

PVT5 (Precision and Accuracy Check)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472055PX
Basic UDI-DI: B-472055PX
Reference: 472055
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems AQUA CAL 2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-471291Q6
Basic UDI-DI: B-471291Q6
Reference: 471291
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems AQUA CAL 1

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-471288QH
Basic UDI-DI: B-471288QH
Reference: 471288
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems AQUA CAL 3

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-471294QC
Basic UDI-DI: B-471294QC
Reference: 471294
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Drug Calibrator 3 Plus

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-471080PP
Basic UDI-DI: B-471080PP
Reference: 471080
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 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

CAL 5 PLUS Calibrator 5 Plus

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469975SQ
Basic UDI-DI: B-469975SQ
Reference: 469975
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details