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457 device results listed.

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GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109219N2
Basic UDI-DI: B-109219N2
Reference: 109219
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

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-109217MW
Basic UDI-DI: B-109217MW
Reference: 109217
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

IVD Annex II List BIVDDNo longer on the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109216MU
Basic UDI-DI: B-109216MU
Reference: 109216
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

IVD Annex II List BIVDDNo longer on the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109215MS
Basic UDI-DI: B-109215MS
Reference: 109215
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D Panel-E

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109214MQ
Basic UDI-DI: B-109214MQ
Reference: 109214
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D Panel-D

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109213MN
Basic UDI-DI: B-109213MN
Reference: 109213
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D Panel-C

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109212ML
Basic UDI-DI: B-109212ML
Reference: 109212
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM II Calcium2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109211MJ
Basic UDI-DI: B-109211MJ
Reference: 109211
EMDN: W01010303
EMDN description: CALCIUM
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:45

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM D AMY2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109082MX
Basic UDI-DI: B-109082MX
Reference: 109082
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:44

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SPOTCHEM II Amylase2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-109081MV
Basic UDI-DI: B-109081MV
Reference: 109081
EMDN: W01010107
EMDN description: AMYLASE - TOTAL
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 05:44

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)