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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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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

D-BS6605463P

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

D-BS4858985Q

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

D-BP122483X3

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

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

Manufacturer products View details

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-BI000042269
Basic UDI-DI: B-BI000042269
Reference: BI0000422
EMDN: W0103010502
EMDN description: ABNORMAL BLOOD CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:24

Manufacturer products View details

B-Trol ESR Control L1

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Labquality Oy
Manufacturer SRN: FI-MF-000019825
UDI-DI: D-BI000042167
Basic UDI-DI: B-BI000042167
Reference: BI0000421
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:24

Manufacturer products View details

B-Trol ESR Control L1

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Labquality Oy
Manufacturer SRN: FI-MF-000019825
UDI-DI: D-BI000042065
Basic UDI-DI: B-BI000042065
Reference: BI0000420
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:24

Manufacturer products View details

B-Trol Plus Control Abnormal Level

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testingSingle use

Manufacturer: Labquality Oy
Manufacturer SRN: FI-MF-000019825
UDI-DI: D-BI000017269
Basic UDI-DI: B-BI000017269
Reference: BI0000172
EMDN: W0103010502
EMDN description: ABNORMAL BLOOD CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:24

Manufacturer products View details

B-Trol Plus Control Normal Level

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testingSingle use

Manufacturer: Labquality Oy
Manufacturer SRN: FI-MF-000019825
UDI-DI: D-BI000017065
Basic UDI-DI: B-BI000017065
Reference: BI0000170
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:24

Manufacturer products View details

D-BD007680QT

XN CHECK BF

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BD007680QT
Basic UDI-DI: B-BD007680QT
Reference: BD007680
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-BC553492T3

XN CAL

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BC553492T3
Basic UDI-DI: B-BC553492T3
Reference: BC553492
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-BA448553S7

XN CHECK BF

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BA448553S7
Basic UDI-DI: B-BA448553S7
Reference: BA448553
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Sight OLO CBC Test Kit

TK1

IVD generalIVDDNo longer on the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: S.D. Sight Diagnostics Ltd
Manufacturer SRN: IL-MF-000026216
UDI-DI: B787TK10
Basic UDI-DI: B-B787TK10
Reference: TK1
EMDN: W0103010103
EMDN description: COMPLETE CELL COUNT
First on market country: Northern Ireland
Authorised representative: CEpartner4U
Last updated: 12.07.2026 23:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-AW7985698S

e-CHECK(XS)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-AW7985698S
Basic UDI-DI: B-AW7985698S
Reference: AW798569
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 12.07.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-AT9653195J

EIGHTCHECK-3WP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-AT9653195J
Basic UDI-DI: B-AT9653195J
Reference: AT965319
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 12.07.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details