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EUDAMED Device Search

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

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02.08.2026 12:03

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IMMAGE Immunochemistry Systems PAB Prealbumin Reagent

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

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IMMAGE Immunochemistry Systems C3 Complement C3 Reagent

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

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

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IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent

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

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IMMAGE Immunochemistry Systems C4 Complement C4 Reagent

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

IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent

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 IGG Immunoglobulin G Reagent

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

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IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent

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

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IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A Reagent

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

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 IGM Immunoglobulin M Reagent

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221195
Basic UDI-DI: 150995901447610L6
Reference: 447610
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 LPAX Lipoprotein (a) Reagent

IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221171
Basic UDI-DI: 150995901447450L8
Reference: 447450
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

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IMMAGE Immunochemistry Systems TRF Transferrin Reagent

IMMAGE Immunochemistry Systems TRF Transferrin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180171
Basic UDI-DI: 150995901447630LC
Reference: 447630
EMDN: W0102010307
EMDN description: TRANSFERRIN
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 MA Microalbumin Reagent

IMMAGE Immunochemistry Systems MA Microalbumin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180164
Basic UDI-DI: 150995901447690LW
Reference: 447690
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
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

N Latex FLC kappa

IVDR_27_MAR EB_C_PROF_REAG_N_La_FLC_2

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031410
Basic UDI-DI: 0405686902230V4
Reference: 10482437
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

Dimension Vista Transferrin Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_TRF

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006258
Basic UDI-DI: 0405686900929W8
Reference: 10445910
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

Dimension Vista Prealbumin Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_PREALB

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006210
Basic UDI-DI: 0405686900921VQ
Reference: 10445906
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

Dimension Vista Microalbumin Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_MALB

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006203
Basic UDI-DI: 0405686900920VN
Reference: 10445905
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

Dimension Vista Immunoglobulin M Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_IGM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006197
Basic UDI-DI: 0405686900919W5
Reference: 10445904
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details

Dimension Vista Immunoglobulin G Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_IGG

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006180
Basic UDI-DI: 0405686900918W3
Reference: 10445903
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:25

Manufacturer products View details