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452 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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-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

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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

BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 5-Part-Diff Auto Hematology Analyzer

BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-2-96P
Basic UDI-DI: B-2-96P
Reference: /
EMDN: W0202010102
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 14:26

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BH-7000、BH-7010、BH-7020、BH-7030、BH-7060、BH-7080 Automatic Hematology Analyzer

BH-7000、BH-7010、BH-7020、BH-7030、BH-7060、BH-7080

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-2-86M
Basic UDI-DI: B-2-86M
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

BH-51S 5-Part-Diff Auto Hematology Analyzer

BH-51S

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-2-66H
Basic UDI-DI: B-2-66H
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

BH-5360CRP 5-Part-Diff Auto Hematology Analyzer

BH-5360CRP

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-2-56F
Basic UDI-DI: B-2-56F
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 14:26

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URIT-5380 5-Part-Diff Auto Hematology Analyzer

URIT-5380

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-2-46D
Basic UDI-DI: B-2-46D
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 14:26

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URIT-5500 5-Part-Diff Auto Hematology Analyzer

URIT-5500

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-2-36B
Basic UDI-DI: B-2-36B
Reference: /
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 14:26

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COULTER AcT 5diff Autoloader Hematology Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-175356PW
Basic UDI-DI: B-175356PW
Reference: 175356
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: 11.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

08809317540610

ADAMII & ADAMII™ CD34 Kit

IVD generalIVDDOn the marketAnimal tissuesInstrumentKitProfessional testingReagent

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540610
Basic UDI-DI: B-08809317540610
Reference: ADAM2 & CD34K-025
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

08809317540504

ADAM-rWBC2 & ADAM-rWBC Kit

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagent

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540504
Basic UDI-DI: B-08809317540504
Reference: ADAM-rWBC2 & ADAM-rWBC Kit
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Greece
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

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Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813373
Basic UDI-DI: 69444138H60SPG
Reference: H66
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813380
Basic UDI-DI: 69444138H60SPG
Reference: H68
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813397
Basic UDI-DI: 69444138H60SPG
Reference: H69
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

IVD Class BNot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813403
Basic UDI-DI: 69444138H60SPG
Reference: H60S
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details