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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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Access Total βhCG (Reagent Pack)

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226213
Basic UDI-DI: 150995901AccTBhCGLW
Reference: A85264
EMDN: -
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access 25(OH) Vitamin D Total Reagent Pack

IVD Class BNot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226558
Basic UDI-DI: 150995901AccVitDDxRV
Reference: A98856
EMDN: -
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 1

IVD Class CNot specifiedOn the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226916
Basic UDI-DI: 150995901450120JA
Reference: 450120
EMDN: -
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226947
Basic UDI-DI: 150995901447070KS
Reference: 447070
EMDN: -
EMDN description: RHEUMATOID FACTORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems BUF 3 Buffer 3

IVD Class ANot specifiedOn the marketAnimal tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226961
Basic UDI-DI: 150995901447050KL
Reference: 447050
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226985
Basic UDI-DI: 150995901447020KB
Reference: 447020
EMDN: -
EMDN description: IMMUNOGLOBULIN G
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems High Sensitivity C-Reactive Protein (CRPH) Reagent

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227005
Basic UDI-DI: 150995901474630LQ
Reference: 474630
EMDN: -
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227029
Basic UDI-DI: 150995901474620LM
Reference: 474620
EMDN: -
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access Thyroglobulin (Reagent Pack)

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227173
Basic UDI-DI: 150995901AccTgKC
Reference: 33860
EMDN: -
EMDN description: THYROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access Total T3 Reagent Pack

IVD Class BNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227210
Basic UDI-DI: 150995901AccTT3PF
Reference: 33830
EMDN: -
EMDN description: TRIIODOTHYRONINE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level C

IVD Class CNot specifiedOn the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227326
Basic UDI-DI: 150995901465440LD
Reference: 465440
EMDN: -
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 3

IVD Class CNot specifiedOn the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227333
Basic UDI-DI: 150995901450164JW
Reference: 450164
EMDN: -
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 2

IVD Class CNot specifiedOn the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227357
Basic UDI-DI: 150995901450163JU
Reference: 450163
EMDN: -
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access Intrinsic Factor Antibody QC

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590229108
Basic UDI-DI: 150995901AccIFAbQC2C
Reference: 387999
EMDN: -
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access Intrinsic Factor Antibody

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590229146
Basic UDI-DI: 150995901AccIFAbZ2
Reference: 387992
EMDN: -
EMDN description: INTRINSIC FACTOR (BLOCKING ANTIBODY)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI Immunoassay System Reaction Vessels

IVD Class ANot specifiedOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590229979
Basic UDI-DI: 150995901386167M2
Reference: 386167
EMDN: -
EMDN description: SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Access Substrate

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590229986
Basic UDI-DI: 150995901AccSubstrateHR
Reference: 81906
EMDN: -
EMDN description: SUBSTRATES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems C4 Complement C4 Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230449
Basic UDI-DI: 150995901446490LD
Reference: 446490
EMDN: -
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230456
Basic UDI-DI: 150995901446480LA
Reference: 446480
EMDN: -
EMDN description: HAPTOGLOBIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230470
Basic UDI-DI: 150995901446460L4
Reference: 446460
EMDN: -
EMDN description: IMMUNOGLOBULIN A
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details