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Emdyca

Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Coagulation inhibitors/thrombophilia markers

Lupus anticoagulant

EMDN code W0103020606

11 manufacturers, 40 models including 40 on the market, 7 countries

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Manufacturers registered in Europe (EUDAMED) 11
  • 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
Dymind EU representative : Eunitor GmbH (Germany) China
6 others
 – 98/79 regulationdept@dymind.com EUDAMED record Report an error
Stago FDA France
1 other
 B IVDR, 98/79 EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands) China – 98/79 Website info@medcaptain.com EUDAMED record Report an error
Technoclone Austria – 98/79 Website regulatory@technoclone.com 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
r2 Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States – 98/79 Website qa@r2diagnostics.com EUDAMED record Report an error
Sclavo Italy – 98/79 qa@sclavo.it EUDAMED record Report an error
Tcoag FDA Ireland – 98/79 Website EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Biodatacorp EU representative : mdi Europa GmbH (Germany) United States A IVDR Website customer.service@biodatacorp.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA Germany B IVDR Website contact@siemens-healthineers.com 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) 6

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
Biomedica ADI Inc. – DVVconfirm 5 DVVconfirm 10 DVVtest 25 DVVtest 10 registered
Precision Biologic Present in Europe in other categories Canada CRYOcheck™ LA Check™ CRYOcheck™ LA Sure™ K990580 (1999)
BIT Analytical Solutions GmbH Germany – registered
Biomedica Diagnostics Inc Canada – registered
Dsrv, Inc. United States – K132076 (2014)
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories United States – registered

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