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463 device results listed.

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Portable Automatic Multi-Function Analyzer (iCARE-1300)

iCARE-1300

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 16934175044457
Basic UDI-DI: 6934175002A0002NG
Reference: 10500077
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

5-Part Auto Hematology Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300342
Basic UDI-DI: 6936895BS0092J
Reference: BS009
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Autosampler

Hematology analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999860094487
Basic UDI-DI: 5999883586A5XW
Reference: AS5-1
EMDN: W0202010180
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:44

Manufacturer products View details

Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method

Norma Icon-5 OP

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200023
Basic UDI-DI: 59991062Icon5OPU7
Reference: NO50H
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method

Norma Icon-5

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000014244
UDI-DI: 05999106200016
Basic UDI-DI: 59991062Icon5A6
Reference: NI50H
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:35

Manufacturer products View details

Cellagon 5 Pro Hematology Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000332
Basic UDI-DI: 599279505WR
Reference: g-Cell5Pro
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

TruCell

IVD Class ANot specifiedOn the market

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763914
Basic UDI-DI: 5065023763TC60001TV
Reference: TC60001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruCell

TC100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763846
Basic UDI-DI: 5065023763TC100R8
Reference: TC10001
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

04260154344009

Extended IPU

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Sysmex Europe SE
Manufacturer SRN: DE-MF-000022332
UDI-DI: 04260154344009
Basic UDI-DI: 426015434Extended-IPUE8
Reference: ZE004218
EMDN: W0202010192
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products 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 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 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