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682 device results listed.

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Abacus 5 Hematology Analyzer with SSM

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: 05999883586280
Basic UDI-DI: 5999883586A5XW
Reference: A5SSM-1
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 04.08.2026 21:58

Manufacturer products View details

ADVIA 560 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: 00630414601816
Basic UDI-DI: 0405686901597WC
Reference: 11170842
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: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Hemaray 55CRP

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-W0202010185
Basic UDI-DI: B-W0202010185
Reference: Hemaray 55CRP
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

miLab™ Cartridge BCM

CBCA

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Noul Co., Ltd.
Manufacturer SRN: KR-MF-000033621
UDI-DI: 18800100110116
Basic UDI-DI: B-18800100110116
Reference: CBCA
EMDN: W0202010192
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 19:16

Manufacturer products Authorised representative products Authorised representative actors View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431674720314
Basic UDI-DI: B-08431674720314
Reference: 1705111
EMDN: W0202010285
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673755850
Basic UDI-DI: B-08431673755850
Reference: 1705681
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673755843
Basic UDI-DI: B-08431673755843
Reference: 1705610
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673755836
Basic UDI-DI: B-08431673755836
Reference: 1705680
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673755829
Basic UDI-DI: B-08431673755829
Reference: 1705600
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673720308
Basic UDI-DI: B-08431673720308
Reference: 1705181
EMDN: W0202010285
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673720292
Basic UDI-DI: B-08431673720292
Reference: 1705110
EMDN: W0202010285
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673720285
Basic UDI-DI: B-08431673720285
Reference: 1705180
EMDN: W0202010285
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

No

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673720278
Basic UDI-DI: B-08431673720278
Reference: 1705100
EMDN: W0202010285
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

X100HT With Full Field Peripheral Blood Smear (PBS) Application

X100HT With Full Field Peripheral Blood Smear (PBS) Application

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Scopio Labs Ltd.
Manufacturer SRN: IL-MF-000025129
UDI-DI: 07290018417140
Basic UDI-DI: B-07290018417140
Reference: SC-SYS-00002
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

X100 With Full Field Peripheral Blood Smear (PBS) Application

X100 With Full Field Peripheral Blood Smear (PBS) Application

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Scopio Labs Ltd.
Manufacturer SRN: IL-MF-000025129
UDI-DI: 07290018417133
Basic UDI-DI: B-07290018417133
Reference: SC-SYS-00001
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

DP-H10

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493092926
Basic UDI-DI: B-06970493092926
Reference: PO-0014-02
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 03.08.2026 23:59

Manufacturer products Authorised representative products Authorised representative actors View details

KT 62

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802372
Basic UDI-DI: B-06950334802372
Reference: KT 62
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Analytical module + sample feeder + computer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202227813
Basic UDI-DI: B-06942202227813
Reference: Analytical module + sample feeder + computer
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Systerm

BF-7600PLus

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202227806
Basic UDI-DI: B-06942202227806
Reference: BF-7600PLus
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details

Analytical module + sample feeder +computer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202227790
Basic UDI-DI: B-06942202227790
Reference: Analytical module + sample feeder +computer
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:54

Manufacturer products Authorised representative products Authorised representative actors View details