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457 device results listed.

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Uriflet S 10HB

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73520HF
Basic UDI-DI: B-73520HF
Reference: 73520
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

Uriflet S 10HA

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-73519HW
Basic UDI-DI: B-73519HW
Reference: 73519
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Hungary
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:06

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Lactate Pro 2 (LT-1730)

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-48303H7
Basic UDI-DI: B-48303H7
Reference: 48303
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:17

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Lactate Pro 2 (LT-1730)

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-48302H5
Basic UDI-DI: B-48302H5
Reference: 48302
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:17

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GLUCOCARD X-meter (GT-1910)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47546HU
Basic UDI-DI: B-47546HU
Reference: 47546
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:07

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GLUCOCARD X-meter (GT-1910)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47536HR
Basic UDI-DI: B-47536HR
Reference: 47536
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:07

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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-47396HZ
Basic UDI-DI: B-47396HZ
Reference: 47396
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

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-47395HX
Basic UDI-DI: B-47395HX
Reference: 47395
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

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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-47393HT
Basic UDI-DI: B-47393HT
Reference: 47393
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

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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-47389J4
Basic UDI-DI: B-47389J4
Reference: 47389
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

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ELUENT 80CT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47301GU
Basic UDI-DI: B-47301GU
Reference: 47301
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:02

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COLUMN UNIT 80T

IVD generalIVDDOn the marketProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47300GS
Basic UDI-DI: B-47300GS
Reference: 47300
EMDN: W0201050280
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:01

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SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47215H2
Basic UDI-DI: B-47215H2
Reference: 47215
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47214GY
Basic UDI-DI: B-47214GY
Reference: 47214
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47204GV
Basic UDI-DI: B-47204GV
Reference: 47204
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD Vital (GT-1050)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testingSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46907HX
Basic UDI-DI: B-46907HX
Reference: 46907
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46748J3
Basic UDI-DI: B-46748J3
Reference: 46748
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46746HX
Basic UDI-DI: B-46746HX
Reference: 46746
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46744HT
Basic UDI-DI: B-46744HT
Reference: 46744
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-46708HP
Basic UDI-DI: B-46708HP
Reference: 46708
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details