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PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20707FM
Basic UDI-DI: B-20707FM
Reference: 20707
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20705FH
Basic UDI-DI: B-20705FH
Reference: 20705
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20704FF
Basic UDI-DI: B-20704FF
Reference: 20704
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem BA (PA-4140)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20504F5
Basic UDI-DI: B-20504F5
Reference: 20504
EMDN: W0201010203
EMDN description: BLOOD-AMMONIA CHECKERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem BA (PA-4140)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20503F3
Basic UDI-DI: B-20503F3
Reference: 20503
EMDN: W0201010203
EMDN description: BLOOD-AMMONIA CHECKERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EZ (SP-4430)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-18306GC
Basic UDI-DI: B-18306GC
Reference: 18306
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EZ (SP-4430)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-18304G8
Basic UDI-DI: B-18304G8
Reference: 18304
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION MAX (AX-4030)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14506FS
Basic UDI-DI: B-14506FS
Reference: 14506
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION MAX (AX-4030)

IVD generalIVDDNo longer on the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14504FN
Basic UDI-DI: B-14504FN
Reference: 14504
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14440FM
Basic UDI-DI: B-14440FM
Reference: 14440
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14405FK
Basic UDI-DI: B-14405FK
Reference: 14405
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

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

AUTION EYE (AI-4510)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106026LY
Basic UDI-DI: B-106026LY
Reference: 106026
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105885NH
Basic UDI-DI: B-105885NH
Reference: 105885
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 (DB-3910)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105581MS
Basic UDI-DI: B-105581MS
Reference: 105581
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102678MM
Basic UDI-DI: B-102678MM
Reference: 102678
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102677MK
Basic UDI-DI: B-102677MK
Reference: 102677
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
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

AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102676MH
Basic UDI-DI: B-102676MH
Reference: 102676
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

AUTION MAX (AX-4030)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102674MD
Basic UDI-DI: B-102674MD
Reference: 102674
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
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

AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100528LK
Basic UDI-DI: B-100528LK
Reference: 100528
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details