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

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01.08.2026 18:27

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62 device results listed.

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MRX FDP Clear High Control

FDP Clear High Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320301
Basic UDI-DI: B-27350060320301
Reference: K5019
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

MRX FDP Clear Low Control

FDP Clear Low Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320295
Basic UDI-DI: B-27350060320295
Reference: K5018
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 16:17

Manufacturer products View details

CoaguDx Quality Control

Level 1：6 vial×1 mL Level 2：6 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413645
Basic UDI-DI: B-06978896413645
Reference: W-CL1-QC-6
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：3 vial×1 mL Level 2：3 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413638
Basic UDI-DI: B-06978896413638
Reference: W-CL1-QC-3
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：2 vial×1 mL Level 2：2 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413621
Basic UDI-DI: B-06978896413621
Reference: W-CL1-QC-2
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguDx Quality Control

Level 1：1 vial×1 mL Level 2：1 vial×1 mL

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896413614
Basic UDI-DI: B-06978896413614
Reference: W-CL1-QC-1
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101882

1.0 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101882
Basic UDI-DI: B-06974671101882
Reference: DR-CAL-CK-A026
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi D-Dimer Controls

D-Dimer Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145558727
Basic UDI-DI: B-06947145558727
Reference: 1602047153QLSN
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi FDP Controls

FDP Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145558628
Basic UDI-DI: B-06947145558628
Reference: 1602047152QLSN
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi Coagulation Controls

Coagulation Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145558550
Basic UDI-DI: B-06947145558550
Reference: 1601040003SN
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolumi Coagulation Controls

Coagulation Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145558543
Basic UDI-DI: B-06947145558543
Reference: 1601040004SN
EMDN: W0103020799
EMDN description: HAEMOSTASIS CONTROLS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® FIBRINOGEN Test Set

904se