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GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108489NS
Basic UDI-DI: B-108489NS
Reference: 108489
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108488NQ
Basic UDI-DI: B-108488NQ
Reference: 108488
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108487NN
Basic UDI-DI: B-108487NN
Reference: 108487
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108486NL
Basic UDI-DI: B-108486NL
Reference: 108486
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108484NG
Basic UDI-DI: B-108484NG
Reference: 108484
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108483NE
Basic UDI-DI: B-108483NE
Reference: 108483
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108485NJ
Basic UDI-DI: B-108485NJ
Reference: 108485
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108482NC
Basic UDI-DI: B-108482NC
Reference: 108482
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S onyx (GT-7120)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108481NA
Basic UDI-DI: B-108481NA
Reference: 108481
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S onyx (GT-7120)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108480N8
Basic UDI-DI: B-108480N8
Reference: 108480
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108479NP
Basic UDI-DI: B-108479NP
Reference: 108479
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108478NM
Basic UDI-DI: B-108478NM
Reference: 108478
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108477NK
Basic UDI-DI: B-108477NK
Reference: 108477
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108476NH
Basic UDI-DI: B-108476NH
Reference: 108476
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 04:37

Manufacturer products Authorised representative products Authorised representative actors View details

AutionIDaten (AE-4070)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108203MC
Basic UDI-DI: B-108203MC
Reference: 108203
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 Urea/BUN

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-107839NQ
Basic UDI-DI: B-107839NQ
Reference: 107839
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-107828NK
Basic UDI-DI: B-107828NK
Reference: 107828
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Spain
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

A1C HD CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106959NU
Basic UDI-DI: B-106959NU
Reference: 106959
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 001 A1C HD

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106549N5
Basic UDI-DI: B-106549N5
Reference: 106549
EMDN: W01019002
EMDN description: ELECTROPHORESIS MEDIA (UNASSIGNABLE)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 001 (CE-8810)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106548N3
Basic UDI-DI: B-106548N3
Reference: 106548
EMDN: W020105010202
EMDN description: CAPILLARY ELECTROPHORESIS SYSTEMS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details