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Emdyca

Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Platelet factors

Platelet factor 4

EMDN code W0103020402

4 manufacturers, 10 models including 10 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 4
  • 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
Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) United States A, C IVDR EUDAMED record Report an error
Milenia Biotec Germany – 98/79 Website info@milenia-biotec.de EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) United States B IVDR Website Regulatory@werfen.com EUDAMED record Report an error
Stago FDA France – 98/79 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.

Other manufacturers known in the United States (FDA) 3

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
HYPHEN BIOMED Present in Europe in other categories United States ZYMUTEST HIA MonoStrip IgG ZYMUTEST HIA IgG ZYMUTEST HIA IgGAM ZYMUTEST HIA MonoStrip IgGAM K071255 (2007)
AKERS BIOSCIENCES, INC. United States PIFA PLUSS® PF4 Rapid Assay PIFA® Heparin/PF4 Rapid Assay registered
Biokit, S.A. Present in Europe in other categories Spain – registered

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