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635 device results listed.

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h560 5-part Differential Hematology Analyzer

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: 35999883586328
Basic UDI-DI: 5999883586A5XW
Reference: A5-1
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Hungary
Authorised representative: -
Last updated: 16.07.2026 10:24

Manufacturer products View details

HTI Cleaning Solution

HTI Cleaning Solution

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666376
Basic UDI-DI: 08600086663HERECLECC
Reference: 00-52
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
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

HTI Enzymatic Cleaner Concentrate

HTI Enzymatic Cleaner Concentrate

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666369
Basic UDI-DI: 08600086663HEREENZCV3
Reference: 00-51
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
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

HTI Enzymatic Cleaner

HTI Enzymatic Cleaner

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666352
Basic UDI-DI: 08600086663HEREENZE6
Reference: 00-41
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
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

HTI Detergent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666345
Basic UDI-DI: 08600086663HEREDETCS
Reference: 00-31
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
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

HTI Diluent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666321
Basic UDI-DI: 08600086663HEREDILCN
Reference: 11-12
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
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

HTI Lytic Reagent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666338
Basic UDI-DI: 08600086663HERELYT1WP
Reference: 11-81
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
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

HTI MicroCC20-Plus

HTI MicroCC20-Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: High Technology Inc.
Manufacturer SRN: US-MF-000036184
UDI-DI: 00860008666307
Basic UDI-DI: 08600086663HEAR01T4
Reference: MCC-2000
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
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

HTI MicroCC25-Plus

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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

UniCel DxH 690T Coulter Cellular Analysis System

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

Manufacturer products Authorised representative products Authorised representative actors View details