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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

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-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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

XL -180 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143165
Basic UDI-DI: 8592156CCIN0050SE
Reference: INS00038
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

Manufacturer products View details

Microlab 300LX