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634 device results listed.

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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

COULTER DxH Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233730
Basic UDI-DI: 150995901HEMCLEANERXZ
Reference: 628022
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Retic Pack

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233723
Basic UDI-DI: 150995901HEMRETICPACK4R
Reference: 628021
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Diff Pack

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233716
Basic UDI-DI: 150995901HEMDIFFPACKQJ
Reference: 628020
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER DxH Cell Lyse (1L)

Coulter DxH Cell Lyse

IVD Class AIVDR 2017/746On the marketReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233693
Basic UDI-DI: 150995901HEMLYSEQK
Reference: 628018
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter DxH Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590233686
Basic UDI-DI: 150995901HEMDILUENT5R
Reference: 628017
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

VerifyNow™ System

86000

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Accriva Diagnostics, Inc.
Manufacturer SRN: US-MF-000009902
UDI-DI: 10711234500040
Basic UDI-DI: 0711234500043LW
Reference: 86000
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

VerifyNow

70068

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: Accriva Diagnostics, Inc.
Manufacturer SRN: US-MF-000009902
UDI-DI: 10711234150122
Basic UDI-DI: 0711234150125M4
Reference: 70068
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

VerifyNow™ System

85062

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: Accriva Diagnostics, Inc.
Manufacturer SRN: US-MF-000009902
UDI-DI: 10711234150115
Basic UDI-DI: 0711234150118M7
Reference: 85062
EMDN: W0202010202
EMDN description: SEMI-AUTOMATED HEMATOLOGY ANALYSERS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

SPINCELL 3n

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673951023
Basic UDI-DI: B-08431673951023
Reference: 5006105
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:39

Manufacturer products View details

SPINCELL 5 Plus(+)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673950736
Basic UDI-DI: B-08431673950736
Reference: 5006107
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 01:39

Manufacturer products View details

RET-5

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673435028
Basic UDI-DI: B-08431673435028
Reference: U7100210A
EMDN: W0202010185
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: -
Last updated: 30.07.2026 01:38

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: 06976117452732
Basic UDI-DI: 6970493090608001PL
Reference: XQ-0001-02
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
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