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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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467 device results listed.

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GLUCOCARD S Control Solution

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

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

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

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

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

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

GLUCOCARD SM TEST STRIPS

GLUCOCARD SM TEST STRIPS

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102328LP
Basic UDI-DI: B-102328LP
Reference: 102328
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 TEST STRIPS

GLUCOCARD SM TEST STRIPS

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102327LM
Basic UDI-DI: B-102327LM
Reference: 102327
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 TEST STRIPS

GLUCOCARD SM TEST STRIPS

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102326LK
Basic UDI-DI: B-102326LK
Reference: 102326
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 (GT-7120)

GLUCOCARD SM (GT-7120)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102023KW
Basic UDI-DI: B-102023KW
Reference: 102023
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101954MF
Basic UDI-DI: B-101954MF
Reference: 101954
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101953MD
Basic UDI-DI: B-101953MD
Reference: 101953
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

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-101726LY
Basic UDI-DI: B-101726LY
Reference: 101726
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

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-101718LZ
Basic UDI-DI: B-101718LZ
Reference: 101718
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

CALIBRATOR Lite

CALIBRATOR Lite

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101714LR
Basic UDI-DI: B-101714LR
Reference: 101714
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION Lite H

HEMOLYSIS WASHING SOLUTION Lite H

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101712LM
Basic UDI-DI: B-101712LM
Reference: 101712
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADAMS A1c (HA-8380V)

ADAMS A1c (HA-8380V)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101622LK
Basic UDI-DI: B-101622LK
Reference: 101622
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

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-101542LL
Basic UDI-DI: B-101542LL
Reference: 101542
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Test Strips

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-101541LJ
Basic UDI-DI: B-101541LJ
Reference: 101541
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101494M2
Basic UDI-DI: B-101494M2
Reference: 101494
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details