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Emdyca

Manufacturer

Responsebio

CanadaLegal entities : Response Biomedical Corp.

Markets : Romania · United States

Approvals : EU – class A · United States (FDA) – 510(k) : 7 · class I, II · latest in 2009 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

Website

3 categories, 4 models including 2 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
D-dimer W0103020503 – 98/79 EUDAMED record Report an error
Immunochemistry readers W0201020201 A IVDR EUDAMED record Report an error
Haemostasis standards and calibrators RT & POC No model still on the market W010302080502 – 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.

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