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HTI MicroCC25-Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666314
Basic UDI-DI: 08600086663HEAR02T6
Reference: MCC-3000
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: MedEnvoy Global BV
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Para 12 Plus

IVD Class BIVDR 2017/746On the marketHuman tissues

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000211
Basic UDI-DI: 0844509012+MH
Reference: 218924
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802396
Basic UDI-DI: 69503348KT06RT
Reference: KT-42
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 04:26

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802402
Basic UDI-DI: 69503348KT06RT
Reference: KT-40
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 04:26

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D-RT-7600SV

RT-7600

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-RT-7600SV
Basic UDI-DI: B-RT-7600SV
Reference: RT-7600
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:32

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D-Hemaray86FV

Hemaray 86

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-Hemaray86FV
Basic UDI-DI: B-Hemaray86FV
Reference: Hemaray 86
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: 14.07.2026 01:00

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D-Hemaray83FP

Hemaray 83

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-Hemaray83FP
Basic UDI-DI: B-Hemaray83FP
Reference: Hemaray 83
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:00

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NS Biotec blood cell counter

Hema 25

IVD generalIVDDNo longer on the marketInstrumentProfessional testing

Manufacturer: NS BIOTEC
Manufacturer SRN: EG-MF-000032515
UDI-DI: D-Hema25XJ
Basic UDI-DI: B-Hema25XJ
Reference: NS Biotec blood cell counter hema 25
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 01:00

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NS Biotec blood cell counter

Hema 21

IVD generalIVDDNo longer on the marketInstrumentProfessional testing

Manufacturer: NS BIOTEC
Manufacturer SRN: EG-MF-000032515
UDI-DI: D-Hema21XA
Basic UDI-DI: B-Hema21XA
Reference: NS Biotec hema 21
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 01:00

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D-FRMF000041783ANALYZERJZ

SW-ONCOANALYZ

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Oncomedics SAS
Manufacturer SRN: FR-MF-000041783
UDI-DI: D-FRMF000041783ANALYZERJZ
Basic UDI-DI: B-FRMF000041783ANALYZERJZ
Reference: SW-ONCOANALYZ
EMDN: W0202010282
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 21:46

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AdaptaSpot Smart

1.0

IVD generalIVDDOn the marketInstrument

Manufacturer: SPOTLAB SL
Manufacturer SRN: ES-MF-000044194
UDI-DI: D-ESMF000044194ADSYJ
Basic UDI-DI: B-ESMF000044194ADSYJ
Reference: SPL-0001
EMDN: W02020199
EMDN description: CELL COUNTING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 13.07.2026 21:02

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UniCel DxH 690T Coulter Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C34520UV
Basic UDI-DI: B-C34520UV
Reference: C34520
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:53

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UniCel® DxH 900 Coulter® Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C11478UC
Basic UDI-DI: B-C11478UC
Reference: C11478
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:52

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UniCel® DxH 800 Coulter® Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B66445WA
Basic UDI-DI: B-B66445WA
Reference: B66445
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 00:00

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Sight OLO

OLO-E1

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testing

Manufacturer: S.D. Sight Diagnostics Ltd
Manufacturer SRN: IL-MF-000026216
UDI-DI: B787OLOE10
Basic UDI-DI: B-B787OLOE10
Reference: OLO-E1
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 12.07.2026 23:54

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxH 800 Coulter Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B24802UJ
Basic UDI-DI: B-B24802UJ
Reference: B24802
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:50

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UniCel DxH 600 Coulter Cellular Analysis System

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B23858V6
Basic UDI-DI: B-B23858V6
Reference: B23858
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:50

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Z-GEM 5R+

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753903376
Basic UDI-DI: B-42625753903376
Reference: Z-GEM 5R+
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details

Z-GEM 5+

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753903208
Basic UDI-DI: B-42625753903208
Reference: Z-GEM 5+
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details

Z-GEM 5

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753903130
Basic UDI-DI: B-42625753903130
Reference: Z-GEM 5
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details