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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 Unconjugated Estriol (Reagent Pack)

C22255

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590702120
Basic UDI-DI: 150995901AccEstriol56
Reference: C22255
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Total Immunoglobulin E (IgE)

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590701727
Basic UDI-DI: 150995901C22529QK
Reference: C22529
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxH SMS II Coulter Cellular Analysis

UniCel DxH SMS II Coulter Cellular Analysis System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590701567
Basic UDI-DI: 150995901HEMINSTRUMENTRF
Reference: C11477
EMDN: W0202010180
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access Sensitive Estradiol Calibrator S0

B97145

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590699406
Basic UDI-DI: 150995901AccSE2S0CalMV
Reference: B97145
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access Sensitive Estradiol Calibrators

B84494

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590699390
Basic UDI-DI: 150995901AccSE2Cal28
Reference: B84494
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access Sensitive Estradiol

B84493

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590699383
Basic UDI-DI: 150995901AccSE2MT
Reference: B84493
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

AVANTI J-15R, 200-230 VAC IVD

Avanti J-15 series centrifuge

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590694913
Basic UDI-DI: 150995901AVANTIJ15FZ
Reference: B99515
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

DxFLEX Sheath Fluid

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590670825
Basic UDI-DI: 150995901LS-1-SheathND
Reference: B73613
EMDN: W0103080699
EMDN description: REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access 25(OH) Vitamin D Total Calibrators

A98857

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590663421
Basic UDI-DI: 150995901AccVitDDxCalJG
Reference: A98857
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access 25(OH) Vitamin D Total Calibrators

B24839

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590663414
Basic UDI-DI: 150995901AccVitDA2Cal3F
Reference: B24839
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access Wash Buffer II

A16792

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590624774
Basic UDI-DI: 150995901AccWBII33
Reference: A16792
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allegra X-30, IVD, 100V, 50/60Hz

Allegra X-30 series centrifuge

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590616434
Basic UDI-DI: 150995901ALLEGRAX30XH
Reference: B06319
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access hFSH Calibrators

33525

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575250
Basic UDI-DI: 150995901AcchFSHCalCK
Reference: 33525
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access hLH Reagent Pack

33510

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575243
Basic UDI-DI: 150995901AcchLHSA
Reference: 33510
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Access Ferritin Reagent Pack

33020

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575052
Basic UDI-DI: 150995901AccFerRX
Reference: 33020
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Access Ferritin Calibrators

33025

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575045
Basic UDI-DI: 150995901AccFerCalJW
Reference: 33025
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Access hFSH Reagent Pack

33520

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575236
Basic UDI-DI: 150995901AcchFSH77
Reference: 33520
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Access Prolactin (Reagent Pack)

33530

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590575229
Basic UDI-DI: 150995901AccProlD8
Reference: 33530
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

TQ Prep

COULTER TQ-Prep Workstation

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590563547
Basic UDI-DI: 150995901LSTQPREPHN
Reference: 6605429
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

Flow-Count Fluorospheres

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590542450
Basic UDI-DI: 150995901FLUROSPHRSRP
Reference: 7547053
EMDN: W0103080499
EMDN description: FLOW CYTOMETRY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details