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

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IOTest CD3-PC7

IVD Class CNot specifiedOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590391553
Basic UDI-DI: 150995901LSANTIBODYREAQ2
Reference: 737657
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
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

Optima XPN – 80K (IVD)

IVD Class ANot specifiedOn the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590415822
Basic UDI-DI: 150995901OPTIMALK
Reference: A99839
EMDN: W02069003
EMDN description: CENTRIFUGES
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

Optima XE – 100K (IVD)

IVD Class ANot specifiedOn the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590415846
Basic UDI-DI: 150995901OPTIMALK
Reference: A99836
EMDN: W02069003
EMDN description: CENTRIFUGES
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

Optima XE – 90K (IVD)

IVD Class ANot specifiedOn the marketInstrument

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590415860
Basic UDI-DI: 150995901OPTIMALK
Reference: A99833
EMDN: W02069003
EMDN description: CENTRIFUGES
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

Access Vitamin B12 II Calibrators

D06116

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590786519
Basic UDI-DI: 150995907AccVB12CalRT
Reference: D06116
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Beckman Coulter Flow cytometer

DxFLEX

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000011854
UDI-DI: 15099590717834
Basic UDI-DI: 150995907DxFLEXVE
Reference: C02846
EMDN: W0202040180
EMDN description: CYTOFLOWMETERS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

ClearLLab Compensation Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Beckman Coulter India Private Limited
Manufacturer SRN: IN-MF-000010115
UDI-DI: 15099590686574
Basic UDI-DI: 150995906B74074UC
Reference: B74074
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

ClearLLab LS Lymphoid Screen Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Beckman Coulter India Private Limited
Manufacturer SRN: IN-MF-000010115
UDI-DI: 15099590686567
Basic UDI-DI: 150995906B74073UA
Reference: B74073
EMDN: W0103080101
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Power Link

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

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