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Emdyca

Manufacturer

Biosynex

France, SwitzerlandLegal entities : BIOSYNEX, BIOSYNEX Swiss SA

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

Public contracts won : France 20

EU representative : BIOSYNEX (France)

Website reglementaire@biosynex.com

39 categories, 62 models including 56 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
Controls infectious immunology - RT & POC W0105094001 – 98/79 EUDAMED record Report an error
Tetanus (clostridium t.) W0105011709 – 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007 – 98/79 EUDAMED record Report an error
Multiple parasites panels W01050704 B IVDR, 98/79 EUDAMED record Report an error
Other virus combinations - multiplex NA reagents W0105070302 C IVDR, 98/79 EUDAMED record Report an error
Legionella - RT & POC W0105090108 – 98/79 EUDAMED record Report an error
Faeces collection devices W05019001 A IVDR EUDAMED record Report an error
H. pylori - RT & POC W0105090102 – 98/79 EUDAMED record Report an error
Other multiple pathogens - RT & POC W0105090699 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - NA reagents W0105050309 C IVDR EUDAMED record Report an error
Strep. a - RT & POC W0105090103 – 98/79 EUDAMED record Report an error
Strep. pneumoniae - RT & POC W0105090109 – 98/79 EUDAMED record Report an error
Samples collection devices - other W05019099 A IVDR EUDAMED record Report an error
All infectious diseases controls - NAT W0105080808 – 98/79 EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents W0105011607 C IVDR EUDAMED record Report an error
Chlamydia ag - RT & POC W0105090101 – 98/79 EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC W0105090106 B IVDR EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 – 98/79 EUDAMED record Report an error
Coronavirus / influenza - RT & POC W0105090601 – 98/79 EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC W0105090501 – 98/79 EUDAMED record Report an error
Cryptococcus W0105060303 C IVDR EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 C IVDR EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004 – 98/79 EUDAMED record Report an error
IVD instruments - other W0299 A IVDR EUDAMED record Report an error
Leptospira - NA reagents W0105011604 C IVDR EUDAMED record Report an error
Medical cushions - other V080399 I MDR EUDAMED record Report an error
Non-contact digital thermometers V0301010202 IIa MDR EUDAMED record Report an error
Norovirus W0105040616 – 98/79 EUDAMED record Report an error
Other virology controls - inf.imm. W0105080804 – 98/79 EUDAMED record Report an error
Parasitology controls - inf.imm. W0105080805 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 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
Streptococcal direct antigen detection W0105011101 – 98/79 EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 A IVDR EUDAMED record Report an error
Virology - RT & POC - other W0105099099 – 98/79 EUDAMED record Report an error
D-dimer - RT & POC No model still on the market W0103020803 – 98/79 EUDAMED record Report an error
General coagulation tests - other No model still on the market W0103020199 C IVDR EUDAMED record Report an error
Strep. b detection by NA reagents No model still on the market W0105011104 C IVDR EUDAMED record Report an error

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