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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 Hybritech PSA Diluent

IVD Class CNot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590816919
Basic UDI-DI: 150995909AccHPSASamDilB2
Reference: 37206
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ASO Anti-Streptolysin O Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221188
Basic UDI-DI: 150995901447620L9
Reference: 447620
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent

IVD Class BIVDR 2017/746On 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: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227005
Basic UDI-DI: 150995901474630LQ
Reference: 474630
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 08.10.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech free PSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817893
Basic UDI-DI: 150995909AccHfPSATG
Reference: C22846
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 05.10.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Access BNP II

D06227

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818418
Basic UDI-DI: 150995909BNPIIEN
Reference: D06227
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access 25(OH) Vitamin D Total

A98856

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817718
Basic UDI-DI: 150995909AccVitDDxZ5
Reference: A98856
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Hybritech PSA

37200

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590816896
Basic UDI-DI: 150995909AccHPSA76
Reference: 37200
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:16

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter Sample Cup 2 mL

81902

IVD Class AIVDR 2017/746On the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817121
Basic UDI-DI: 15099590981902WA
Reference: 652730
EMDN: W05020180
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:06

Manufacturer products Authorised representative products Authorised representative actors View details

Access CK-MB

386371

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817022
Basic UDI-DI: 150995909AccCKMB4S
Reference: 386371
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP

33211

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590816544
Basic UDI-DI: 150995909AccAFP300WZ
Reference: 33211
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP Reagent

33210

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590816537
Basic UDI-DI: 150995909AccAFPR6
Reference: 33210
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

Access Ferritin

33020

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590816513
Basic UDI-DI: 150995909AccFerW7
Reference: 33020
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

Access 2 Module, DxC 500i

C13252

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817848
Basic UDI-DI: 150995909DxC500iW5
Reference: C13252
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 24.09.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System

IVD Class ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817275
Basic UDI-DI: 150995909UniCelDxIG9
Reference: 973100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 23.09.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

Access BNP II

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818456
Basic UDI-DI: 150995909BNPIIEN
Reference: D24688
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Access 25(OH) Vitamin D Total

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817923
Basic UDI-DI: 150995909AccVitDDxZ5
Reference: C28646
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 04:05

Manufacturer products Authorised representative products Authorised representative actors View details

Access CK-MB

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590818364
Basic UDI-DI: 150995909AccCKMB4S
Reference: D00534
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

Access Ferritin

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817879
Basic UDI-DI: 150995909AccFerW7
Reference: C22490
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000051071
UDI-DI: 15099590817909
Basic UDI-DI: 150995909AccAFPR6
Reference: C22847
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: -
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 22.09.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details