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Emdyca

Manufacturer

Seegene

South KoreaLegal entities : Seegene, Inc.

Markets : Germany · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 1 · class I, II · latest in 2015 · see on the FDA website

Public contracts won : Germany 1

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website info@seegene.com

17 categories, 63 models including 63 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101
7 others
A IVDR EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503
5 others
B, C IVDR, 98/79 EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504
4 others
B, C IVDR, 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, 98/79 EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents W0105070502 B, C IVDR, 98/79 EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 – 98/79 EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents W0105070505 C IVDR, 98/79 EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 – 98/79 EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 C IVDR, 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 C IVDR, 98/79 EUDAMED record Report an error
Mycoplasma / ureaplasma reagents - other W0105010899 C IVDR EUDAMED record Report an error
Robotic sample processing systems - other W02060199 A IVDR EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 C IVDR, 98/79 EUDAMED record Report an error
H. pylori reagents - other W0105010499 B IVDR, 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
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Robotic sample processing systems - hardware accessories W02060180 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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