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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

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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

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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

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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

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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

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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

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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

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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

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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-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

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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-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

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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

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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

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AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100525LD
Basic UDI-DI: B-100525LD
Reference: 100525
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

08806134664017

GCM-110

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134664017
Basic UDI-DI: B-08806134664017
Reference: GCM110M10
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Slovakia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

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CERA-CHEK™ Lactate Measuring System

L 400

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065158201
Basic UDI-DI: B-08800065158201
Reference: L400M10
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

XL-1000 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156145534
Basic UDI-DI: 8592156CCIN0053SL
Reference: INS00010
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 22:49

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XL-640 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143202
Basic UDI-DI: 8592156CCIN0052SJ
Reference: INS00008
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 22:49

Manufacturer products View details

XL-200 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143851
Basic UDI-DI: 8592156CCIN0051SG
Reference: INS00002
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 22:49

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