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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 16:25

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273 device results listed.

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SPOTCHEM II STAT-1

SPOTCHEM II STAT-1

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77418JK
Basic UDI-DI: B-77418JK
Reference: 77418
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Liver-1

SPOTCHEM II Liver-1

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77417JH
Basic UDI-DI: B-77417JH
Reference: 77417
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II PANEL-V

SPOTCHEM II PANEL-V

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77189JT
Basic UDI-DI: B-77189JT
Reference: 77189
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II KENSHIN-2

SPOTCHEM II KENSHIN-2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77188JR
Basic UDI-DI: B-77188JR
Reference: 77188
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II PANEL-2

SPOTCHEM II PANEL-2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77185JK
Basic UDI-DI: B-77185JK
Reference: 77185
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Kidney-2

SPOTCHEM II Kidney-2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77187JP
Basic UDI-DI: B-77187JP
Reference: 77187
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Heart-2

SPOTCHEM II Heart-2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77186JM
Basic UDI-DI: B-77186JM
Reference: 77186
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II PANEL-1

SPOTCHEM II PANEL-1

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77184JH
Basic UDI-DI: B-77184JH
Reference: 77184
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:20

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II STAT-1

SPOTCHEM II STAT-1

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77183JF
Basic UDI-DI: B-77183JF
Reference: 77183
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Liver-1

SPOTCHEM II Liver-1

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77182JD
Basic UDI-DI: B-77182JD
Reference: 77182
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems NO FOAM

SYNCHRON Systems NO FOAM

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469110QL
Basic UDI-DI: B-469110QL
Reference: 469110
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent 1 DIL1

Sample Diluent 1 DIL1

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-467826RQ
Basic UDI-DI: B-467826RQ
Reference: 467826
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Antifoam

SYNCHRON Systems Antifoam

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445967R7
Basic UDI-DI: B-445967R7
Reference: 445967
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Wash Concentrate II

SYNCHRON Systems Wash Concentrate II

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445865QW
Basic UDI-DI: B-445865QW
Reference: 445865
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Myocardial Enzyme Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245219
Basic UDI-DI: B-15065026245219
Reference: TA10010
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose and Lipid Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245202
Basic UDI-DI: B-15065026245202
Reference: TA10009
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Emergency Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245196
Basic UDI-DI: B-15065026245196
Reference: TA10008
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Liver Function Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245189
Basic UDI-DI: B-15065026245189
Reference: TA10007
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Renal Function Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245172
Basic UDI-DI: B-15065026245172
Reference: TA10006
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245165
Basic UDI-DI: B-15065026245165
Reference: TA10005
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details