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Emdyca

Manufacturer

ELITechGroup

Italy, United StatesLegal entities : ELITechGroup Inc., ElitechGroup S.p.A.

First countries of placing on the market declared in EUDAMED : Germany, Italy

Public contracts won : Italy 26

EU representative : Medical Technology Promedt Consulting GmbH (Germany)

Website info@elitechgroup.com

40 categories, 57 models including 57 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
All infectious diseases controls - NAT W0105080808
1 other
– 98/79 EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 B IVDR EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents W0105070505 C IVDR, 98/79 EUDAMED record Report an error
Standards and calibrators for all infections/ NAT W0105080908 – 98/79 EUDAMED record Report an error
Cmv - NA reagents W0105040205 C IVDR EUDAMED record Report an error
Hhv-6,7,8 - NA reagents W0105040524 C IVDR EUDAMED record Report an error
Hsv - NA reagents W0105040311 C IVDR EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503 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 EUDAMED record Report an error
Sweat test stimulators Z12080408 I, IIa MDR EUDAMED record Report an error
Adenovirus - NA reagents W0105040501 C IVDR EUDAMED record Report an error
Aspergillus - NA reagents W0105060401 – 98/79 EUDAMED record Report an error
Bk virus - NA reagents W0105040522 C IVDR EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents W0105011607 B IVDR EUDAMED record Report an error
C.difficile by NA reagents W0105011804 – 98/79 EUDAMED record Report an error
Candida auris - NA reagents W0105060404 B IVDR EUDAMED record Report an error
Chloride analysers W0201040203 – 98/79 EUDAMED record Report an error
Cytocentrifuges W02069004 A IVDR EUDAMED record Report an error
Ebv - NA reagents W0105040403 C IVDR EUDAMED record Report an error
Enterovirus - NA reagents W0105040502 C IVDR EUDAMED record Report an error
Hepatitis b virus - NA reagents W0105020216 D IVDR EUDAMED record Report an error
Hepatitis c virus - NA reagents W0105020307 D IVDR EUDAMED record Report an error
Hepatitis e virus - NA reagents W0105020507 – 98/79 EUDAMED record Report an error
HIV 1 - NA reagents W0105030107 D IVDR EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 B IVDR EUDAMED record Report an error
Jc virus - NA reagents W0105040523 C IVDR EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 – 98/79 EUDAMED record Report an error
Norovirus - NA reagents W0105040516 B IVDR EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables W02050185 A IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Osmometers W02079017 – 98/79 EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 C IVDR EUDAMED record Report an error
Parvovirus b 19 - NA reagents W0105040509 C IVDR EUDAMED record Report an error
Pneumocystis - NA reagents W0105060405 C IVDR EUDAMED record Report an error
Romanowsky stains W0103010302 A IVDR EUDAMED record Report an error
Supplemental NA reagents W0105900103 A IVDR EUDAMED record Report an error
Toxoplasma - NA reagents W0105050105 C IVDR EUDAMED record Report an error
Urogenital mycoplasma detection by NA reagents W010501080302 C IVDR EUDAMED record Report an error
Varicella zoster - NA reagents W0105040904 C IVDR EUDAMED record Report an error
West nile virus - NA reagent W0105040526 – 98/79 EUDAMED record Report an error

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