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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

The Lab 004 AST (GOT)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106406ME
Basic UDI-DI: B-106406ME
Reference: 106406
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 ALT (GPT)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106405MC
Basic UDI-DI: B-106405MC
Reference: 106405
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

OSMO STATION Control Solution Set

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106342MD
Basic UDI-DI: B-106342MD
Reference: 106342
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMS A1c (HA-8190V)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106341MB
Basic UDI-DI: B-106341MB
Reference: 106341
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 Ca

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106334ME
Basic UDI-DI: B-106334ME
Reference: 106334
EMDN: W01010303
EMDN description: CALCIUM
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 UA

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106333MC
Basic UDI-DI: B-106333MC
Reference: 106333
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details