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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Hematology Analyzer Fluorescent Platelets Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL22011017E
Basic UDI-DI: B-EBL22011017E
Reference: EBL2201101
EMDN: W0103010505
EMDN description: PLATELET CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Reticulocyte Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL22011007C
Basic UDI-DI: B-EBL22011007C
Reference: EBL2201100
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL22010047F
Basic UDI-DI: B-EBL22010047F
Reference: EBL2201004
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL22010037D
Basic UDI-DI: B-EBL22010037D
Reference: EBL2201003
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL22010027B
Basic UDI-DI: B-EBL22010027B
Reference: EBL2201002
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL220100179
Basic UDI-DI: B-EBL220100179
Reference: EBL2201001
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:23

Manufacturer products Authorised representative products Authorised representative actors View details

XN CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CW6792878P
Basic UDI-DI: B-CW6792878P
Reference: CW679287
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

XN CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CU2486464X
Basic UDI-DI: B-CU2486464X
Reference: CU248646
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

XN CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CT7029734B
Basic UDI-DI: B-CT7029734B
Reference: CT702973
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

e-CHECK(XS)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CL552365XY
Basic UDI-DI: B-CL552365XY
Reference: CL552365
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 05:07

Manufacturer products Authorised representative products Authorised representative actors View details

XN-L CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-CC211992RE
Basic UDI-DI: B-CC211992RE
Reference: CC211992
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER 6C Plus Cell Control

COULTER 6C Plus Cell Control

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-C07297V5
Basic UDI-DI: B-C07297V5
Reference: C07297
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 13.07.2026 03:50

Manufacturer products Authorised representative products Authorised representative actors View details

XN-L CHECK

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BS6605463P
Basic UDI-DI: B-BS6605463P
Reference: BS660546
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

EIGHTCHECK-3WP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BS4858985Q
Basic UDI-DI: B-BS4858985Q
Reference: BS485898
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

e-CHECK(XS)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BP122483X3
Basic UDI-DI: B-BP122483X3
Reference: BP122483
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Hb Hemoglobin Test Strip

BK-H2

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-H2SR
Basic UDI-DI: B-BK-H2SR
Reference: BK-H2
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Hb Hemoglobin Control Solution

BK-CSH32

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-CSH329T
Basic UDI-DI: B-BK-CSH329T
Reference: BK-CSH32
EMDN: W0103010606
EMDN description: HAEMATOLOGY CONTROLS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Hb Hemoglobin Control Solution

BK-CSH31

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-CSH319R
Basic UDI-DI: B-BK-CSH319R
Reference: BK-CSH31
EMDN: W0103010606
EMDN description: HAEMATOLOGY CONTROLS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Hb Hemoglobin Control Solution

BK-CSH30

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-CSH309P
Basic UDI-DI: B-BK-CSH309P
Reference: BK-CSH30
EMDN: W0103010606
EMDN description: HAEMATOLOGY CONTROLS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

B-Trol ESR Control L2

B-Trol ESR Control L2

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Labquality Oy
Manufacturer SRN: FI-MF-000019825
UDI-DI: D-BI00004236B
Basic UDI-DI: B-BI00004236B
Reference: BI0000423
EMDN: W0103010502
EMDN description: ABNORMAL BLOOD CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:24

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