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

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467 device results listed.

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SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47204GV
Basic UDI-DI: B-47204GV
Reference: 47204
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD Vital (GT-1050)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46907HX
Basic UDI-DI: B-46907HX
Reference: 46907
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46748J3
Basic UDI-DI: B-46748J3
Reference: 46748
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46746HX
Basic UDI-DI: B-46746HX
Reference: 46746
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46744HT
Basic UDI-DI: B-46744HT
Reference: 46744
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46708HP
Basic UDI-DI: B-46708HP
Reference: 46708
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46745HV
Basic UDI-DI: B-46745HV
Reference: 46745
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46707HM
Basic UDI-DI: B-46707HM
Reference: 46707
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46706HK
Basic UDI-DI: B-46706HK
Reference: 46706
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

COLUMN UNIT 80

IVD generalIVDDOn the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42513GA
Basic UDI-DI: B-42513GA
Reference: 42513
EMDN: W0201050280
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL DILUTION SET 80

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42512G8
Basic UDI-DI: B-42512G8
Reference: 42512
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION 80H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42511G6
Basic UDI-DI: B-42511G6
Reference: 42511
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80CV

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42510G4
Basic UDI-DI: B-42510G4
Reference: 42510
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80A

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42508GH
Basic UDI-DI: B-42508GH
Reference: 42508
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

ELUENT 80B

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-42509GK
Basic UDI-DI: B-42509GK
Reference: 42509
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:17

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-38995JR
Basic UDI-DI: B-38995JR
Reference: 38995
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:58

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-34847HD
Basic UDI-DI: B-34847HD
Reference: 34847
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMS A1c (HA-8180T)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-34116FX
Basic UDI-DI: B-34116FX
Reference: 34116
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMS A1c (HA-8180T)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-34114FT
Basic UDI-DI: B-34114FT
Reference: 34114
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMS A1c (HA-8180V)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-34111FM
Basic UDI-DI: B-34111FM
Reference: 34111
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details