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Emdyca

Manufacturer

Eurospital

ItalyLegal entities : Eurospital Spa

Markets : Italy · United States

Approvals : EU – class A, B · United States (FDA) – 510(k) : 5 · class II · latest in 2019 · see on the FDA website

Public contracts won : Italy 2

regulatory@eurospital.it

11 categories, 19 models including 19 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Bacteriology - NA reagents - other W0105011699 – 98/79 EUDAMED record Report an error
Haematology rapid tests & point of care - other W0103010699 – 98/79 EUDAMED record Report an error
H. pylori - RT & POC W0105090102 B IVDR, 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays W0105010802 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) W0201020102 A IVDR EUDAMED record Report an error
Automated systems for the management of pre and post-analysis W02060101 A IVDR EUDAMED record Report an error
Faeces collection devices W05019001 A IVDR EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101 A IVDR EUDAMED record Report an error
Various hematology / histology / cytology instruments - other W02029099 – 98/79 EUDAMED record Report an error
Various sample processing instruments - software accessories W02069082 A IVDR 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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