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Emdyca

Manufacturer

Bioeksen

TürkiyeLegal entities : Bioeksen AR GE Teknolojileri Anonim Şirketi

Markets : Türkiye

Approvals : EU – class A

Website info@bioeksen.com.tr

35 categories, 73 models including 73 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Respiratory tract infections - multiplex NA reagents W0105070503
9 others
– 98/79 EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504
2 others
– 98/79 EUDAMED record Report an error
Bacteriology - NA reagents - other W0105011699 – 98/79 EUDAMED record Report an error
Samples analyses, plastic tubes with additives W050301020101 A IVDR EUDAMED record Report an error
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents W0105070202 – 98/79 EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents W0105070505 – 98/79 EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 – 98/79 EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents W0105070201 – 98/79 EUDAMED record Report an error
Mycobacteria reagents - other W0105010799 – 98/79 EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 – 98/79 EUDAMED record Report an error
Other virus combinations - multiplex NA reagents W0105070302 – 98/79 EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 – 98/79 EUDAMED record Report an error
Robotic sample processing systems - other W02060199 A IVDR EUDAMED record Report an error
Virology - NA reagents - other W0105040599 – 98/79 EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents W0105011607 – 98/79 EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc W0105900201 A IVDR EUDAMED record Report an error
C.difficile toxin a/b detection W0105011802 – 98/79 EUDAMED record Report an error
Crimean-congo hemorrhagic fever (cchf) - NA reagents W0105040529 – 98/79 EUDAMED record Report an error
Full genotyping high-risk + low-risk HPV - NA reagents W0105041004 – 98/79 EUDAMED record Report an error
H. pylori detection by NA reagents W0105010403 – 98/79 EUDAMED record Report an error
IVD instruments - other W0299 A IVDR EUDAMED record Report an error
Measles - NA reagents W0105040704 – 98/79 EUDAMED record Report an error
Mycology NA reagents - other W0105060499 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments - rapid and point of care tests - IVD medical device software W02050392 A IVDR EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems W02050116 A IVDR EUDAMED record Report an error
Other HPV - NA reagents W0105041005 – 98/79 EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents W0105070502 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 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 – 98/79 EUDAMED record Report an error
Strep. a detection by NA reagents W0105011103 – 98/79 EUDAMED record Report an error
Strep. b detection by NA reagents W0105011104 – 98/79 EUDAMED record Report an error
Streptococcal reagents - other W0105011199 – 98/79 EUDAMED record Report an error
Tropical fever - multiplex NA reagents W0105070506 – 98/79 EUDAMED record Report an error
West nile virus - NA reagent W0105040526 – 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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