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480 device results listed.

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IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-6605580ZU
Basic UDI-DI: B-6605580ZU
Reference: 6605580
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: 17.07.2026 03:46

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-629029QJ
Basic UDI-DI: B-629029QJ
Reference: 629029
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: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-61003FV

BF8201P, BF8202P

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-61003FV
Basic UDI-DI: B-61003FV
Reference: /
EMDN: W0202010103
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HIGH ROUTINE (Throughput > 120 samples/hr)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 17.07.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-61001FR

BF8201

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-61001FR
Basic UDI-DI: B-61001FR
Reference: /
EMDN: W0202010103
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HIGH ROUTINE (Throughput > 120 samples/hr)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 17.07.2026 03:16

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Automatic Hematology Analyzer

MH 60X

IVD generalIVDDOn the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600176
Basic UDI-DI: B-06954417600176
Reference: NA
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Northern Ireland
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

MH 60 Pro

IVD generalIVDDOn the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600183
Basic UDI-DI: B-06954417600183
Reference: NA
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Northern Ireland
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 16.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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

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 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

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

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

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

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

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-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

Manufacturer products Authorised representative products Authorised representative actors View details