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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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23.09.2026 08:13

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467 device results listed.

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SPOTCHEM D AST (GOT)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77938KJ
Basic UDI-DI: B-77938KJ
Reference: 77938
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D AMY

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77937KG
Basic UDI-DI: B-77937KG
Reference: 77937
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D ALT (GPT)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77936KE
Basic UDI-DI: B-77936KE
Reference: 77936
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D ALP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77935KC
Basic UDI-DI: B-77935KC
Reference: 77935
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D ALB

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77934KA
Basic UDI-DI: B-77934KA
Reference: 77934
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D CRP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77805JW
Basic UDI-DI: B-77805JW
Reference: 77805
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:24

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77743JZ
Basic UDI-DI: B-77743JZ
Reference: 77743
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:23

Manufacturer products Authorised representative products Authorised representative actors View details

W0101060101

GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77742JX
Basic UDI-DI: B-77742JX
Reference: 77742
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:23

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77741JV
Basic UDI-DI: B-77741JV
Reference: 77741
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:23

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD G sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77734JY
Basic UDI-DI: B-77734JY
Reference: 77734
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:23

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM i-Pack CRP Wide

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77610JD
Basic UDI-DI: B-77610JD
Reference: 77610
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
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 Calcium