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358 device results listed.

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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

Pentra XLR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006405
Basic UDI-DI: 361023pentra_xlrEA
Reference: 1280110003, 1280110005, 1280110007, 1280110009, 1280110011, 1280110013,1280110015, 1280110016, 1300039852, 1300039853
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 21:15

Manufacturer products View details

ABX Pentra XL80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006399
Basic UDI-DI: 361023pentra_xl80LB
Reference: 1280110025, 1280110027, 1280110029,1280110031,1280110033, 1280110035, 1280110036, 1280110038, 1300039850, 1300039851
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 21:15

Manufacturer products View details

Atellica HEMA 530

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009536
Basic UDI-DI: 361023at_530GF
Reference: 1300128174
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 21:12

Manufacturer products View details

Atellica HEMA 520 CT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009529
Basic UDI-DI: 361023at_520_ct5U
Reference: 1300128173
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 21:12

Manufacturer products View details

Atellica HEMA 520 OT

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009512
Basic UDI-DI: 361023at_520_ot6Y
Reference: 1300128171
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 21:12

Manufacturer products View details

SPINCELL 5 Compact

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673085445
Basic UDI-DI: B-08431673085445
Reference: 5006104
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

Manufacturer products View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117452688
Basic UDI-DI: 697049309W02023012007CS
Reference: XQ-0042-05
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117452756
Basic UDI-DI: 6970493090608002PN
Reference: XQ-0002-01
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117453463
Basic UDI-DI: 697049309W02023012007CS
Reference: XQ-0042-07
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117457027
Basic UDI-DI: 6970493090608002PN
Reference: XQ-0002-05
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117457331
Basic UDI-DI: 6970493090608004PS
Reference: XQ-0004-02
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117457362
Basic UDI-DI: 6970493090608004PS
Reference: XQ-0004-03
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117457591
Basic UDI-DI: 6970493090608004PS
Reference: XQ-0004-05
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117457768
Basic UDI-DI: 6970493090608004PS
Reference: XQ-0004-06
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 25.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

CH8600, CH8601, CH8602, CH8600CRP, CH8601CRP, CH8602CRP

IVD Class BIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066777003
Basic UDI-DI: 697806677CH001HT
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 360 Hematology System

IVDR_67_TTN_DUB-C_B_INST_Hematology System

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414601250
Basic UDI-DI: 0405686901597WC
Reference: 11170841
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details