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

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590583996
Basic UDI-DI: 150995901PLUQ
Reference: B05033
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose

OSR6621

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590060084
Basic UDI-DI: 150995901OSR6621ML
Reference: OSR6621
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:44

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose

OSR6221

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590020101
Basic UDI-DI: 150995901OSR6221LY
Reference: OSR6221
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:43

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter PK7400 Automated Microplate System

B53299

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 14987666543344
Basic UDI-DI: 150995901PK74006D
Reference: B53299
EMDN: W02020399
EMDN description: BLOOD GROUPING INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

MICROPLATE TYPE P4 (12PCS/SET)

ZM062100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 04987666528559
Basic UDI-DI: 150995901ZM062100GD
Reference: ZM062100
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

MICROPLATE TYPE P3 (12PCS/SET)

ZM047000

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 04987666527439
Basic UDI-DI: 150995901ZM047000GM
Reference: ZM047000
EMDN: -
EMDN description: BLOOD GROUPING ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Cup, Plastic (pkg. of 100)

ZM006300

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 04987666524582
Basic UDI-DI: 150995901ZM006300FH
Reference: ZM006300
EMDN: -
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Cup, Glass (pkg. of 100)

ZM006200

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 04987666524575
Basic UDI-DI: 150995901ZM006200FC
Reference: ZM006200
EMDN: -
EMDN description: SAMPLES TRANSPORT, CONTAINERS - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Access p-Tau217 QC

D15499

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590797386
Basic UDI-DI: 150995901D15499RS
Reference: D15499
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
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 p-Tau217 Calibrators

D14563

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590797379
Basic UDI-DI: 150995901D14563R3
Reference: D14563
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
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 p-Tau217

D14170

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590794507
Basic UDI-DI: 150995901D14170QC
Reference: D14170
EMDN: W0102019017
EMDN description: PHOSPHORYLATED TAU (PTAU)
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 MeMed BV QC (Kit)

D05593

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590787127
Basic UDI-DI: 150995901AccMeMedBVQCZ4
Reference: D05593
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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 MeMed BV Calibrator (Kit)

D05592

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590787110
Basic UDI-DI: 150995901AccMeMedBVCalLB
Reference: D05592
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 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access MeMed BV Reagent Kit

D05581

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590787103
Basic UDI-DI: 150995901AccMeMedBVFH
Reference: D05581
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

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-000010288
UDI-DI: 15099590786533
Basic UDI-DI: 150995901BNPIIBE
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: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access Free T4

C76421

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590780982
Basic UDI-DI: 150995901AccFT4BXR
Reference: C76421
EMDN: W01020402
EMDN description: FREE THYROXINE
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 Thyroglobulin Antibody II Reagent Pack

C86552

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590763527
Basic UDI-DI: 150995901AccTGAbBJT
Reference: C86552
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
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 Thyroglobulin Reagent Pack

C71762

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590754501
Basic UDI-DI: 150995901AccTgBRM
Reference: C71762
EMDN: W01020408
EMDN description: THYROGLOBULIN
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 Total T4 II Calibrators

C69048

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590754495
Basic UDI-DI: 150995901AccTT4IICalZ3
Reference: C69048
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 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access Total T4 II Reagent Pack

C69047

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590754488
Basic UDI-DI: 150995901AccTT4IIJC
Reference: C69047
EMDN: W01020407
EMDN description: THYROXINE
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