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

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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: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231910
Basic UDI-DI: 150995901447280L7
Reference: 447280
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems BUF 4 Buffer 4

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231903
Basic UDI-DI: 150995901447420KX
Reference: 447420
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

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IMMAGE Immunochemistry Systems PAB Prealbumin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231897
Basic UDI-DI: 150995901447440L5
Reference: 447440
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems Wash Solution

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231712
Basic UDI-DI: 150995901447060KP
Reference: 447060
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

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IMMAGE Immunochemistry Systems C3 Complement C3 Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230487
Basic UDI-DI: 150995901446450KZ
Reference: 446450
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230470
Basic UDI-DI: 150995901446460L4
Reference: 446460
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230456
Basic UDI-DI: 150995901446480LA
Reference: 446480
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems C4 Complement C4 Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230449
Basic UDI-DI: 150995901446490LD
Reference: 446490
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI Immunoassay System Reaction Vessels

386167

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590229979
Basic UDI-DI: 150995901386167M2
Reference: 386167
EMDN: W050301020180
EMDN description: SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226985
Basic UDI-DI: 150995901447020KB
Reference: 447020
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems BUF 3 Buffer 3

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226961
Basic UDI-DI: 150995901447050KL
Reference: 447050
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226947
Basic UDI-DI: 150995901447070KS
Reference: 447070
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems FER Ferritin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223373
Basic UDI-DI: 150995901447160KU
Reference: 447160
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223885
Basic UDI-DI: 150995901446400KJ
Reference: 446400
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223878
Basic UDI-DI: 150995901446410KM
Reference: 446410
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems UDR

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590223359
Basic UDI-DI: 150995901447250KW
Reference: 447250
EMDN: W05030199
EMDN description: SAMPLES ANALYSES, CONTAINERS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221225
Basic UDI-DI: 150995901447460LB
Reference: 447460
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221218
Basic UDI-DI: 150995901447470LE
Reference: 447470
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ALB Albumin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221201
Basic UDI-DI: 150995901447600L3
Reference: 447600
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details