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

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Access C-Peptide (Reagent Pack)

C33451

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590733377
Basic UDI-DI: 150995901AccCPep56
Reference: C33451
EMDN: W0102060101
EMDN description: C-PEPTIDE
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 C-Peptide (Calibrators)

C31860

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590733360
Basic UDI-DI: 150995901AccCPepCalBR
Reference: C31860
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

DxI 9000 Access Immunoassay Analyzer

C11137

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590732103
Basic UDI-DI: 150995901DXI9000INSTRTQ
Reference: C11137
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: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

DxFlex Daily QC Fluorospheres

DxFLEX Daily QC Fluorospheres

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590730031
Basic UDI-DI: 150995901C39283S6
Reference: C39283
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

Avanti JXN-26, 230V, 50HZ, 24A - IVD centrifuge

Avanti JXN series centrifuge

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590711931
Basic UDI-DI: 150995901AVANTIJXNM3
Reference: B38623
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

Microfuge 20R 220V-240V, 50/60 Hz, IVD

Microfuge 20 series centrifuges

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590711795
Basic UDI-DI: 150995901MICROFUGE2064
Reference: B31611
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

Kaluza C Perpetual License

Kaluza C Software

IVD Class AIVDR 2017/746On the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590705084
Basic UDI-DI: 150995901FCANSYSSWJ2
Reference: C10574
EMDN: W0202040182
EMDN description: CYTOFLOWMETERS - SOFTWARE 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 Unconjugated Estriol (Calibrators)

C22256

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590702137
Basic UDI-DI: 150995901AccEstriolCal5W
Reference: C22256
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 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