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457 device results listed.

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SPOTCHEM D Stat2

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102732M2
Basic UDI-DI: B-102732M2
Reference: 102732
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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SPOTCHEM D Metabolic2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102731LY
Basic UDI-DI: B-102731LY
Reference: 102731
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II PANEL-V2

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102728MB
Basic UDI-DI: B-102728MB
Reference: 102728
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: 11.07.2026 00:57

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SPOTCHEM D Kidney2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102730LW
Basic UDI-DI: B-102730LW
Reference: 102730
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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SPOTCHEM D CRE2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102729MD
Basic UDI-DI: B-102729MD
Reference: 102729
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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SPOTCHEM II Creatinine2

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102726M7
Basic UDI-DI: B-102726M7
Reference: 102726
EMDN: W01010207
EMDN description: CREATININE
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Kidney-3

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102727M9
Basic UDI-DI: B-102727M9
Reference: 102727
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: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II PANEL-V2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102725M5
Basic UDI-DI: B-102725M5
Reference: 102725
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: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Kidney-3

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102724M3
Basic UDI-DI: B-102724M3
Reference: 102724
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: 11.07.2026 00:57

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SPOTCHEM II Creatinine2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102723LZ
Basic UDI-DI: B-102723LZ
Reference: 102723
EMDN: W01010207
EMDN description: CREATININE
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102678MM
Basic UDI-DI: B-102678MM
Reference: 102678
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102677MK
Basic UDI-DI: B-102677MK
Reference: 102677
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102676MH
Basic UDI-DI: B-102676MH
Reference: 102676
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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AUTION MAX (AX-4030)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102674MD
Basic UDI-DI: B-102674MD
Reference: 102674
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102634LZ
Basic UDI-DI: B-102634LZ
Reference: 102634
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102633LX
Basic UDI-DI: B-102633LX
Reference: 102633
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102632LV
Basic UDI-DI: B-102632LV
Reference: 102632
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION Sticks 10V

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102595MG
Basic UDI-DI: B-102595MG
Reference: 102595
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD SM CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102526LV
Basic UDI-DI: B-102526LV
Reference: 102526
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD SM CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102525LT
Basic UDI-DI: B-102525LT
Reference: 102525
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details