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Emdyca

Manufacturer

Igenesis Shanghai

ChinaLegal entities : Igenesis(Shanghai)Co.,Ltd.

Markets : Czechia · Greece · Italy · Netherlands · Portugal · Slovakia · Spain · Türkiye

Approvals : EU – class A, C

EU representative : CMC Medical Devices & Drugs SL (Spain)

support@igenesisbio.com

17 categories, 18 models including 18 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Respiratory tract infections - multiplex NA reagents W0105070503 – 98/79 EUDAMED record Report an error
C.difficile by NA reagents W0105011804 – 98/79 EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 – 98/79 EUDAMED record Report an error
Dengue virus - NA reagents W0105040511 – 98/79 EUDAMED record Report an error
Devices for samples analyses - other W05039099 A IVDR EUDAMED record Report an error
E. coli detection by NA reagents W0105011503 – 98/79 EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 – 98/79 EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 – 98/79 EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 – 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 C IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents W0105070502 – 98/79 EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 – 98/79 EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 – 98/79 EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501 C IVDR EUDAMED record Report an error
Tropical fever - multiplex NA reagents W0105070506 – 98/79 EUDAMED record Report an error
Various sample processing instruments - other W02069099 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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