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218 device results listed.

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Yumizen 1500 (Yumizen SPS connectable)

Yumizen H1500

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008591
Basic UDI-DI: 361023ymz_h1500JQ
Reference: 1300031324, 1300031325, 1300046881, 1300046884
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen SPS

1300024699

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008508
Basic UDI-DI: 361023ymz_spsXJ
Reference: 1300024699
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G Cuvettes

1300036425

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008492
Basic UDI-DI: 361023ymz_g_cuvettesCX
Reference: 1300036425
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G Clean SYS

1300036421

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008485
Basic UDI-DI: 361023ymz_g_clean_sys96
Reference: 1300036421
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G CLEANER

1300036420

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008478
Basic UDI-DI: 361023ymz_g_cleanerP2
Reference: 1300036420
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G SORB

1300036418

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008461
Basic UDI-DI: 361023ymz_g_sorbN7
Reference: 1300036418
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Yumizen G1550

1300036330

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008317
Basic UDI-DI: 361023ymz_g15x0QK
Reference: 1300036331
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Yumizen H2500 (Yumizen SPS connectable)

Yumizen H2500

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008201
Basic UDI-DI: 361023ymz_h2500JX
Reference: 1300031326, 1300031327, 1300031328, 1300031329
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

SAMPLE CUP - GREEN

A11A0176x

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006719
Basic UDI-DI: 361023sample_cup7S
Reference: A11A01766
EMDN: W0503010280
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

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

ABX Pentra HDL Direct 100 CP

A11A01636

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005743
Basic UDI-DI: 361023pentra_hdl_directN8
Reference: A11A01934
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

ABX Pentra Clean-Chem 99 CP

A11A01755

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005552
Basic UDI-DI: 361023pentra_clean_chemHQ
Reference: A11A01789
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Yumizen G CAL

1300036416

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008423
Basic UDI-DI: 361023ymz_g_cal94
Reference: 1300036416
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G CTRL I & II

1300036412

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008416
Basic UDI-DI: 361023ymz_g_contKF
Reference: 1300036412
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G CaCl2 4

1300036386

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008409
Basic UDI-DI: 361023ymz_g_cacl2RT
Reference: 1300036386
EMDN: W0103020901
EMDN description: CALCIUM CHLORIDE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G IMIDAZOL

1300036385

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008393
Basic UDI-DI: 361023ymz_g_imidazol3W
Reference: 1300036385
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G1500

1300036330

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008300
Basic UDI-DI: 361023ymz_g15x0QK
Reference: 1300036330
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G800

1300036318

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008294
Basic UDI-DI: 361023ymz_g800YQ
Reference: 1300036318
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G200

1300036315

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008263
Basic UDI-DI: 361023ymz_g200XS
Reference: 1300036315
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details