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ZEISS Axio Observer 3

Inverted Microscope

IVD Class AIVDR 2017/746No longer on the marketInstrument

Manufacturer: Carl Zeiss Microscopy GmbH
Manufacturer SRN: DE-MF-000024424
UDI-DI: 04064897000068
Basic UDI-DI: 4064897DEA002JP
Reference: 431004-9901-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

Stemi 508

Stereo Microscope

IVD Class AIVDR 2017/746No longer on the marketInstrument

Manufacturer: Carl Zeiss Microscopy GmbH
Manufacturer SRN: DE-MF-000024424
UDI-DI: 04064897000006
Basic UDI-DI: 4064897DEA001JM
Reference: 435064-9000-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

06974675465928

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675465928
Basic UDI-DI: 697467546609029T
Reference: /
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 30.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

06974675464884

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675464884
Basic UDI-DI: 697467546609029T
Reference: /
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 30.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

sthemA 801

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: ARTEION S.A.S
Manufacturer SRN: FR-MF-000035476
UDI-DI: 03760356780021
Basic UDI-DI: 376035678HAEMA0001XY
Reference: 58879
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 21:57

Manufacturer products View details

Yumizen H500 CRP

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009741
Basic UDI-DI: 361023ymz_h500CRPDY
Reference: 1300148023
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen H550E

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009574
Basic UDI-DI: 361023ymz_h550ELU
Reference: 1300129767, 1300129768, 1300129769, 1300129770
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen H500E CT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009567
Basic UDI-DI: 361023ymz_h500E_ctRV
Reference: 1300129763, 1300129764, 1300129765, 1300129766
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen H500E OT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009550
Basic UDI-DI: 361023ymz_h500E_otSZ
Reference: 1300129738, 1300129760, 1300129761, 1300129762
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G800h

1300036318

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009475
Basic UDI-DI: 361023ymz_g800YQ
Reference: 1300115425
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G405

1300121158

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009468
Basic UDI-DI: 361023ymz_g405YE
Reference: 1300121158
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen H550

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009369
Basic UDI-DI: 361023ymz_H550T2
Reference: 1300092726, 1300092727, 1300092728, 1300092729
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen H500 CT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009352
Basic UDI-DI: 361023ymz_h500_ctLS
Reference: 1300092722, 1300092723, 1300092724, 1300092725
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen H500 OT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009345
Basic UDI-DI: 361023ymz_h500_otMW
Reference: 1300092658, 1300092659, 1300092720, 1300092721
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen P8000

1300033327

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008966
Basic UDI-DI: 361023ymz_p8000N8
Reference: 1300033327
EMDN: W0202010182
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

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 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

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