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

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Access Inhibin A (QC)

A36100

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590203061
Basic UDI-DI: 150995901AccInhAQCHF
Reference: A36100
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access Inhibin A (Reagent Pack)

A36097

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590203047
Basic UDI-DI: 150995901AccInhA82
Reference: A36097
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

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Access Thyroglobulin Antibody II Reagent Pack

A32898

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590202910
Basic UDI-DI: 150995901AccTGAb3P
Reference: A32898
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access sTFR Reagent Pack

A32493

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590202811
Basic UDI-DI: 150995901AccsTfRDQ
Reference: A32493
EMDN: W0102070104
EMDN description: SOLUBLE TRANSFERRIN RECEPTOR
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Caps for Recapper, 500/bag

Power Express

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201968
Basic UDI-DI: 150995901PEUA
Reference: A17368
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access Intact PTH Reagent Pack

A16972

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201937
Basic UDI-DI: 150995901AccInPTHQC
Reference: A16972
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

"UniCel DxI Access Wash Buffer II"

A16793

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201906
Basic UDI-DI: 150995901DxIWBII5Y
Reference: A16793
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

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Access IL-6 (Quality Control)

A16371

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201876
Basic UDI-DI: 150995901AccIL6QCDH
Reference: A16371
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access IL-6 (Reagent Pack)

A16369

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201852
Basic UDI-DI: 150995901AccIL6M6
Reference: A16369
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access EPO (Reagent Pack)

A16364

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201838
Basic UDI-DI: 150995901AccEPONE
Reference: A16364
EMDN: W0102070101
EMDN description: ERYTHROPOIETIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access Red Blood Cell Folate Lysing Agent

A14206

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201685
Basic UDI-DI: 150995901AccFolLysAg79
Reference: A14206
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access Free T3

A13422

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201661
Basic UDI-DI: 150995901AccFT3M9
Reference: A13422
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access TPO Antibody

A12985

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201623
Basic UDI-DI: 150995901AccTPOAbN2
Reference: A12985
EMDN: W01020499
EMDN description: THYROID HORMONES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access DHEA-S (Reagent Pack)

A10826

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201432
Basic UDI-DI: 150995901AccDHEASCL
Reference: A10826
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Access Immunoassay System Reaction Vessels

81901

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180249
Basic UDI-DI: 150995901Acc2RVL8
Reference: 81901
EMDN: W050301020180
EMDN description: SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Access 2 mL Sample Cups

81902

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180232
Basic UDI-DI: 15099590181902T2
Reference: 81902
EMDN: W05020180
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Pyridoxal Phosphate Liquid

60106

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590170349
Basic UDI-DI: 15099590160106R5
Reference: 60106
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180157
Basic UDI-DI: 150995901447700L8
Reference: 447700
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180140
Basic UDI-DI: 150995901447710LB
Reference: 447710
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Solution

ODR2000

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590080860
Basic UDI-DI: 150995901ODR2000DF
Reference: ODR2000
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details