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GLUCOFIX TECH

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSMgluD82G6
Basic UDI-DI: B-8012992BGMSMgluD82G6
Reference: 46639 , 46634, 46635, 46636, 46637, 49573, 51344
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

GLUCOFIX TECH B-Ketone Control

GLUCOFIX TECH B-Ketone Control

IVD self-testing devicesIVDDOn the marketNear-patient testingReagentSelf testing

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSCketAX2CA
Basic UDI-DI: B-8012992BGMSCketAX2CA
Reference: 48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555 (UK), 61556 (UK)
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

GlucoMen areo B-Ketone Control

GlucoMen areo B-Ketone Control

IVD self-testing devicesIVDDOn the marketNear-patient testingReagentSelf testing

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSCketAXKU
Basic UDI-DI: B-8012992BGMSCketAXKU
Reference: 47957,48375,48302,48375,47958,48376,48303,47958,48376
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

GlucoMen areo Control

GlucoMen areo Control

IVD Annex II List BIVDDOn the marketNear-patient testingReagentSelf testing

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSCgluB2HX
Basic UDI-DI: B-8012992BGMSCgluB2HX
Reference: 46197,46199,46201,47954,46198,46200,46202,47955
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

GLUCOFIX TECH Control

GLUCOFIX TECH Control

IVD Annex II List BIVDDOn the marketNear-patient testingReagentSelf testing

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSCgluB229Y
Basic UDI-DI: B-8012992BGMSCgluB229Y
Reference: 47686 FR/NL, 46630 FR/NL/IT/UK, 47687 FR/NL, 46631, FR/NL/IT/UK
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: -
Last updated: 12.07.2026 09:29

Manufacturer products View details

Agamatrix Jazz Test Strips

800003712

IVD Annex II List BIVDDOn the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: AgaMatrix, Inc.
Manufacturer SRN: US-MF-000039145
UDI-DI: D-800003712JG
Basic UDI-DI: B-800003712JG
Reference: 800003712
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Northern Ireland
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78730JX
Basic UDI-DI: B-78730JX
Reference: 78730
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78728KC
Basic UDI-DI: B-78728KC
Reference: 78728
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78727KA
Basic UDI-DI: B-78727KA
Reference: 78727
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78726K8
Basic UDI-DI: B-78726K8
Reference: 78726
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78724K4
Basic UDI-DI: B-78724K4
Reference: 78724
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78723K2
Basic UDI-DI: B-78723K2
Reference: 78723
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78722JY
Basic UDI-DI: B-78722JY
Reference: 78722
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78711JT
Basic UDI-DI: B-78711JT
Reference: 78711
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-sensor

GLUCOCARD X-sensor

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78710JR
Basic UDI-DI: B-78710JR
Reference: 78710
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD 01 SENSOR

GLUCOCARD 01 SENSOR

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78610JL
Basic UDI-DI: B-78610JL
Reference: 78610
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Greece
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD 01 SENSOR

GLUCOCARD 01 SENSOR

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78559KD
Basic UDI-DI: B-78559KD
Reference: 78559
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD 01 CONTROL

GLUCOCARD 01 CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78548K8
Basic UDI-DI: B-78548K8
Reference: 78548
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD 01 CONTROL

GLUCOCARD 01 CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78547K6
Basic UDI-DI: B-78547K6
Reference: 78547
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD 01 CONTROL

GLUCOCARD 01 CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78546K4
Basic UDI-DI: B-78546K4
Reference: 78546
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details