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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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01.08.2026 18:27

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CK-MB Control Serum Level 2

ODR30036

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080914
Basic UDI-DI: 150995902ODR30036J8
Reference: ODR30036
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

CK-MB Control Serum Level 1

ODR30035

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080907
Basic UDI-DI: 150995902ODR30035J6
Reference: ODR30035
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

HDL/LDL Cholesterol Control Serum

ODC0005

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070304
Basic UDI-DI: 150995902ODC00058R
Reference: ODC0005
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

Control Serum Level 2

ODC0004

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

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070298
Basic UDI-DI: 150995902ODC00048P
Reference: ODC0004
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

Control Serum Level 1

ODC0003

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070281
Basic UDI-DI: 150995902ODC00038M
Reference: ODC0003
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:30

Manufacturer products View details

Adams CONTROL A1C

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044253
Basic UDI-DI: 4987486BC0109344H8
Reference: 109344
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 29.07.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Adams CALIBRATOR A1C

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044246
Basic UDI-DI: 4987486BC0109343H6
Reference: 109343
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 29.07.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Clonatest

Plasma Protein Multicalibrator Set