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Emdyca

Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Haemostasis rapid tests - RT & POC

Controls/ standards / calibrators for RT & POC

EMDN code W0103020805

15 manufacturers, 36 models including 34 on the market, 8 countries

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Manufacturers registered in Europe (EUDAMED) 15
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Aidian FDA Finland
4 others
 – 98/79 Website eudamed@aidian.eu EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium) China
1 other
 – 98/79 Website EUDAMED record Report an error
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) United States C IVDR, 98/79 EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) China C IVDR, 98/79 EUDAMED record Report an error
Eurolyser Austria – 98/79 Website EUDAMED record Report an error
Milenia Biotec Germany – 98/79 Website info@milenia-biotec.de EUDAMED record Report an error
Tem Innovations FDA Germany – 98/79 EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States – 98/79 quality@healgen.com EUDAMED record Report an error
Hemonart Türkiye – 98/79 Website info@hemonart.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany) China – 98/79 EUDAMED record Report an error
Vitrosens Türkiye C IVDR Website info@vitrosens.com EUDAMED record Report an error
Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands) No model still on the market Canada – 98/79 Website EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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