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

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15099590750312

CellMek SPS

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590750312
Basic UDI-DI: 150995901CellMekH8
Reference: C44603
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV IgM Calibrator

C39448

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745134
Basic UDI-DI: 150995901C39448SE
Reference: C39448
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV IgM QC

C39449

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745141
Basic UDI-DI: 150995901C39449SG
Reference: C39449
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
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 anti-HAV QC

C39446

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745110
Basic UDI-DI: 150995901C39446SA
Reference: C39446
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
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 anti-HAV IgM

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745127
Basic UDI-DI: 150995901C39447SC
Reference: C39447
EMDN: W0105020102
EMDN description: HAV ANTIBODY (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

Access anti-HAV Calibrator

C39445

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745103
Basic UDI-DI: 150995901C39445S8
Reference: C39445
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
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 anti-HAV

C39444

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745097
Basic UDI-DI: 150995901C39444S6
Reference: C39444
EMDN: W0105020102
EMDN description: HAV ANTIBODY (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

Access Total βhCG (Reagent Pack)

C28645

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590744380
Basic UDI-DI: 150995901A9000TBhCGLA
Reference: C28645
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
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

Lumi-Phos PRO

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590744359
Basic UDI-DI: 150995901LumiphosVQ
Reference: B96000
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - 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

Allegra V-15R

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590742461
Basic UDI-DI: 150995901ALLEGRAV15RQ9
Reference: C63125
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 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