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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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04.08.2026 06:01

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Access Hybritech PSA (QC)

37209

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224578
Basic UDI-DI: 150995901AccHPSAQC4X
Reference: 37209
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 2

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223045
Basic UDI-DI: 150995901450125JL
Reference: 450125
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Lipid Control Level 2

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590222925
Basic UDI-DI: 150995901465980MJ
Reference: 465980
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Lipid Control Level 3

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590222918
Basic UDI-DI: 150995901465981ML
Reference: 465981
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Lipid Control Level 4

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590222901
Basic UDI-DI: 150995901465982MN
Reference: 465982
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 3

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590222611
Basic UDI-DI: 150995901450130JD
Reference: 450130
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 1

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590222604
Basic UDI-DI: 150995901450162JS
Reference: 450162
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Access System Check Solution

81910

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221690
Basic UDI-DI: 150995901SysChkBS
Reference: 81910
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Lipid Control Level 1

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221270
Basic UDI-DI: 150995901469905MY
Reference: 469905
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Access sTfR QC2 & QC3

B11057

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590210717
Basic UDI-DI: 150995901AccsTfRQC23YA
Reference: B11057
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Access sTfR QC21

B11056

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590210700
Basic UDI-DI: 150995901AccsTfRQC1TM
Reference: B11056
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech p2PSA (QC)

A56934

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590205362
Basic UDI-DI: 150995901AccHp2PSAQC6F
Reference: A56934
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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 SHBG QC

A48619

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590204051
Basic UDI-DI: 150995901AccSHBGQC3V
Reference: A48619
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 (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 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

Myoglobin

ODR3025

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080808
Basic UDI-DI: 150995902ODR3025ER
Reference: ODR3025
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

D-Dimer Control

ODC0029

IVD Class CIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590070588
Basic UDI-DI: 150995901ODC00298L
Reference: ODC0029
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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

ITA Control Serum Level 3

ODC0016

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070410
Basic UDI-DI: 150995902ODC00168W
Reference: ODC0016
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

ITA Control Serum Level 2

ODC0015

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070403
Basic UDI-DI: 150995902ODC00158U
Reference: ODC0015
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

ITA Control Serum Level 1

ODC0014

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070397
Basic UDI-DI: 150995902ODC00148S
Reference: ODC0014
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details