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Emdyca

Manufacturer

Bioperfectus

ChinaLegal entities : Jiangsu Bioperfectus Technologies Co., Ltd.

Markets : Germany · Netherlands · United States

Approvals : EU – class A, C · United States (FDA) – · class I, II

EU representative : MedNet EC-REP GmbH (Germany)

34 categories, 146 models including 146 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Virology - NA reagents - other W0105040599
21 others
– 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401
14 others
C IVDR, 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101
9 others
A IVDR EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699
7 others
– 98/79 EUDAMED record Report an error
Virology - RT & POC - other W0105099099
4 others
– 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007
3 others
– 98/79 EUDAMED record Report an error
Avian influenza - NA reagents W0105040515 – 98/79 EUDAMED record Report an error
Enterovirus - NA reagents W0105040502 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Influenza & para influenza - NA reagents W0105040504 – 98/79 EUDAMED record Report an error
Other virus combinations - multiplex NA reagents W0105070302 C IVDR, 98/79 EUDAMED record Report an error
C.difficile by NA reagents W0105011804 – 98/79 EUDAMED record Report an error
E. coli detection by NA reagents W0105011503 – 98/79 EUDAMED record Report an error
Hsv - NA reagents W0105040311 – 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
Leishmania W0105050205 – 98/79 EUDAMED record Report an error
Leptospira - NA reagents W0105011604 – 98/79 EUDAMED record Report an error
Lyme detection by NA reagents W0105010605 – 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 – 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus W0105900102 – 98/79 EUDAMED record Report an error
Rotavirus - NA reagents W0105040506 – 98/79 EUDAMED record Report an error
Strep. b detection by NA reagents W0105011104 – 98/79 EUDAMED record Report an error
Various sample processing instruments - other W02069099 A IVDR EUDAMED record Report an error
West nile virus - NA reagent W0105040526 – 98/79 EUDAMED record Report an error
Yersinia - NA reagents W0105011606 – 98/79 EUDAMED record Report an error
Brucella - NA reagents W0105011601 – 98/79 EUDAMED record Report an error
Cmv - NA reagents W0105040205 C IVDR EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other W02050199 A IVDR EUDAMED record Report an error
Pipettes - other W0503020199 A IVDR EUDAMED record Report an error
Samples collection devices - other W05019099 A IVDR 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

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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