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FUJI DRI-CHEM AUTO TIPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410033144
Basic UDI-DI: 454741030100000000000376Z
Reference: 04547410033144
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

DOASENSE Reader

0002

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: DOASENSE GmbH
Manufacturer SRN: DE-MF-000015367
UDI-DI: 04260552660022
Basic UDI-DI: 426055266ReaderXY
Reference: 0002
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:11

Manufacturer products View details

AXINON® System

AXINON System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: numares AG
Manufacturer SRN: DE-MF-000022282
UDI-DI: 04260539610217
Basic UDI-DI: 426053961AX0700X5
Reference: AX0700
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

AXINON® Software

AXINON Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: numares AG
Manufacturer SRN: DE-MF-000022282
UDI-DI: 04260539610194
Basic UDI-DI: 426053961AX0402WS
Reference: AX0402
EMDN: W0201010192
EMDN description: CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

Vario Photometer plus

Vario Photometer plus DP550

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Diaglobal GmbH
Manufacturer SRN: DE-MF-000032608
UDI-DI: 04260152490654
Basic UDI-DI: 426015249DP550VG
Reference: DP550
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

Duo Photometer plus

Diaglobal Photometer DP350

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Diaglobal GmbH
Manufacturer SRN: DE-MF-000032608
UDI-DI: 04260152490647
Basic UDI-DI: 426015249DP350V6
Reference: DP350
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

Selectra ProM

6003-404

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860396
Basic UDI-DI: 37017008ProM-SeriesSL
Reference: 6003-435
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Selectra Mach5

6004-301

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860549
Basic UDI-DI: 37017008Mach-seriesPP
Reference: 6004-301
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Selectra ProS

6003-500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860327
Basic UDI-DI: 37017008ProS-SeriesW6
Reference: 6003-500
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Microlab 300

6002-310

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860037
Basic UDI-DI: 37017008Microlab-seriesHC
Reference: 6002-310
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Pentra C200 Standard

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006689
Basic UDI-DI: 361023pentra_c2006U
Reference: 1280090005
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Pentra C400 ISE

Pentra C400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006559
Basic UDI-DI: 361023pentra_c40076
Reference: 1280241013
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Pentra C200 ISE

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006672
Basic UDI-DI: 361023pentra_c2006U
Reference: 1280090002
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Pentra C400 Standard

Pentra C400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006542
Basic UDI-DI: 361023pentra_c40076
Reference: 1280241012
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

MICROPLATE TYPE P4 (12PCS/SET)

ZM062100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 04987666528559
Basic UDI-DI: 150995901ZM062100GD
Reference: ZM062100
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

CA-310

Clinical Chemistry Analyzer CA-310 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906918
Basic UDI-DI: 0456016CA-310-NOISE9D
Reference: CA000002750
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA-310

Clinical Chemistry Analyzer CA-310 with ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906901
Basic UDI-DI: 0456016CA-310-ISEMZ
Reference: CA000002750
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

SENTiFIT 800

SENTiFIT ®800 Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906895
Basic UDI-DI: 0456016SENTiFIT9D
Reference: 550800
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA-800

Clinical Chemistry Analyzer CA-800 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906871
Basic UDI-DI: 0456016CA-800-NOISECD
Reference: CA000001551
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

CA-800

Clinical Chemistry Analyzer CA-800 with ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906864
Basic UDI-DI: 0456016CA-800-ISEQ9
Reference: CA000001551
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details