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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 Ostase QC

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232290
Basic UDI-DI: 150995901AccOstQCXR
Reference: 37309
EMDN: -
EMDN description: CONTROLS- IMMUNOCHEMISTRY - 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

Access Ostase Reagent Pack

IVD Class BNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232313
Basic UDI-DI: 150995901AccOstUS
Reference: 37300
EMDN: -
EMDN description: BONE ALKALINE PHOSPHATASE (IC)
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 Hybritech free PSA (QC)

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232320
Basic UDI-DI: 150995901AccHfPSAQC6Y
Reference: 37219
EMDN: -
EMDN description: TUMOUR MARKER 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 Hybritech free PSA (Reagent Pack)

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232344
Basic UDI-DI: 150995901AccHfPSAMQ
Reference: 37210
EMDN: -
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
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 Hybritech PSA (Sample Diluent)

IVD Class CNot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232351
Basic UDI-DI: 150995901AccHPSASamDilY7
Reference: 37206
EMDN: -
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
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 CK-MB

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232368
Basic UDI-DI: 150995901AccCKMBXX
Reference: 386371
EMDN: -
EMDN description: CREATINE KINASE - MB ACTIVITY (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

Quick Comp 4 Kit

IVD Class CNot specifiedOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232931
Basic UDI-DI: 15099590LS-1-SetCmp-F7
Reference: 177017
EMDN: -
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233242
Basic UDI-DI: 150995901447480LH
Reference: 447480
EMDN: -
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter DxH Diluent

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233686
Basic UDI-DI: 150995901HEMDILUENT5R
Reference: 628017
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cell Lyse (1L)

IVD Class ANot specifiedOn the marketReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233693
Basic UDI-DI: 150995901HEMLYSEQK
Reference: 628018
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter DxH Cell Lyse

IVD Class ANot specifiedOn the marketReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233709
Basic UDI-DI: 150995901HEMLYSEQK
Reference: 628019
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Diff Pack

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233716
Basic UDI-DI: 150995901HEMDIFFPACKQJ
Reference: 628020
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Retic Pack

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233723
Basic UDI-DI: 150995901HEMRETICPACK4R
Reference: 628021
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cleaner

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233730
Basic UDI-DI: 150995901HEMCLEANERXZ
Reference: 628022
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cleaner

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233747
Basic UDI-DI: 150995901HEMCLEANERXZ
Reference: 628023
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233761
Basic UDI-DI: 150995901HEMCALIBRATORQQ
Reference: 628026
EMDN: -
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233778
Basic UDI-DI: 150995901HEMCONTROL9R
Reference: 628027
EMDN: -
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233785
Basic UDI-DI: 150995901HEMCONTROL9R
Reference: 628028
EMDN: -
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233808
Basic UDI-DI: 150995901HEMCONTROL9R
Reference: 628030
EMDN: -
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter Sample Cup 0.5 mL

IVD Class ANot specifiedOn the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233815
Basic UDI-DI: 150995901651412KT
Reference: 651412
EMDN: -
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details