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

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D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762667
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-20
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764685
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-25
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

BIOPHEN™ Abnormal Control Plasma

Control Plasma

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008313
Basic UDI-DI: 366353700025B5
Reference: 223301
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 24.07.2026 22:55

Manufacturer products View details

BIOPHEN™ Normal Control Plasma

Control Normal Plasma

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537008306
Basic UDI-DI: 366353700034B6
Reference: 223201
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 24.07.2026 22:55

Manufacturer products View details

EASYPLASMA™ Control Set

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537082306
Basic UDI-DI: 366353700025B5
Reference: 225601
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Revohem™ Control 2 Lite

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085819
Basic UDI-DI: 366353700025B5
Reference: AQ518931
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Revohem™ Control 2 Pro

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085826
Basic UDI-DI: 366353700025B5
Reference: AY003713
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Revohem™ Control 1 Pro

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085802
Basic UDI-DI: 366353700034B6
Reference: CV510350
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Revohem™ Control 1 Lite

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: HYPHEN BioMed
Manufacturer SRN: FR-MF-000002214
UDI-DI: 03663537085796
Basic UDI-DI: 366353700034B6
Reference: CX721693
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Coagulation Control

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050720
Basic UDI-DI: B-06974925050720
Reference: BYZKF0303
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation Control

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050683
Basic UDI-DI: B-06974925050683
Reference: BYZKF0203
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation Control

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050645
Basic UDI-DI: B-06974925050645
Reference: BYZKF0103
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

NO

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673939939
Basic UDI-DI: B-08431673939939
Reference: MD1102014
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:26

Manufacturer products View details

0

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673792312
Basic UDI-DI: B-08431673792312
Reference: 1709231
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:25

Manufacturer products View details

D-DIMER CONTROL

0

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673791148
Basic UDI-DI: B-08431673791148
Reference: 1709114
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:25

Manufacturer products View details

0

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673791117
Basic UDI-DI: B-08431673791117
Reference: 1709111
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:25

Manufacturer products View details

NO

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673320140
Basic UDI-DI: B-08431673320140
Reference: TK1102014
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

NO

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673120160
Basic UDI-DI: B-08431673120160
Reference: 1102016
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:20

Manufacturer products View details

NO

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673120146
Basic UDI-DI: B-08431673120146
Reference: SP1102014
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:20

Manufacturer products View details

NO

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673090371
Basic UDI-DI: B-08431673090371
Reference: MX1102014
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:19

Manufacturer products View details