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Emdyca

Manufacturer

Qiagen

Germany, United StatesLegal entities : QIAGEN GmbH, QIAGEN Sciences LLC

Markets : Austria · Denmark · France · Germany · Hungary · Italy · Romania · Spain · Sweden · United States

Approvals : EU – class I, A, C · United States (FDA) – 510(k) : 18 · PMA : 11 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 12 · Italy 11 · Germany 3 · Spain 2 · Sweden 2

EU representative : QIAGEN GmbH (Germany)

Website info@qiagen.com

29 categories, 64 models including 58 on the market, 2 countries

Export to CSV
CategoryEMDN codeRegistered modelsClassContact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101
6 others
 A IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116
2 others
 A IVDR EUDAMED record Report an error
Interferons (α, β, ɣ…) W01030601 – 98/79 EUDAMED record Report an error
Blood collection, tubes without additives or serum separator W050101010202 – 98/79 EUDAMED record Report an error
Cmv - NA reagents W0105040205 – 98/79 EUDAMED record Report an error
DNA genomic preparation devices W02050106 A IVDR EUDAMED record Report an error
Ebv - NA reagents W0105040403 – 98/79 EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents W0105070201 C IVDR EUDAMED record Report an error
Hepatitis b virus - NA reagents W0105020216 – 98/79 EUDAMED record Report an error
HPV reagents - other W0105041099 – 98/79 EUDAMED record Report an error
Hsv - NA reagents W0105040311 – 98/79 EUDAMED record Report an error
IVD general use consumables devices - other accessories W0580 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other W02050199 A IVDR EUDAMED record Report an error
Varicella zoster virus reagents - other W0105040999 – 98/79 EUDAMED record Report an error
Virology - NA reagents - other W0105040599 – 98/79 EUDAMED record Report an error
Various general purpose IVD instruments - other W02079099 A IVDR, 98/79 EUDAMED record Report an error
Laboratory shakers W02070401 A IVDR EUDAMED record Report an error
Samples collection devices - other W05019099 I MDR EUDAMED record Report an error
Blood collection, tubes with additives or serum separator W050101010201 C IVDR EUDAMED record Report an error
Controls - inf. immunology - other W0105080899 – 98/79 EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 C IVDR, 98/79 EUDAMED record Report an error
Laboratory hotplates W02079012 A IVDR EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents W0105070505 C IVDR, 98/79 EUDAMED record Report an error
Nucleic acid hybridization units W02050101 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - hardware accessories W02050180 A IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - IVD medical device software W02050192 C IVDR EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503 C IVDR, 98/79 EUDAMED record Report an error
Tb-igra (interferon-gamma-release assay) W0105010704 C IVDR EUDAMED record Report an error
HPV antigen / antibodies No model still on the market W0105041001 – 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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