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Emdyca

Manufacturer

Orientgene

ChinaLegal entities : Zhejiang Orient Gene Biotech Co., Ltd

Markets : Austria · France · Germany · Greece · Ireland · Italy · Spain · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 1 · class I, II · latest in 2011 · see on the FDA website

EU representative : CMC Medical Devices & Drugs SL (Spain)

97 categories, 273 models including 273 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Virology - RT & POC - other W0105099099
19 others
 B, C IVDR, 98/79 EUDAMED record Report an error
All infectious diseases controls - NAT W0105080808
16 others
 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004
6 others
 C IVDR, 98/79 EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC W0105090501
5 others
 – 98/79 EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents W0105070501
3 others
 – 98/79 EUDAMED record Report an error
Strep. a - RT & POC W0105090103
2 others
 B IVDR, 98/79 EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099
2 others
 A IVDR EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304
1 other
 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401
1 other
 – 98/79 EUDAMED record Report an error
Adenovirus W0105040601 – 98/79 EUDAMED record Report an error
Bacteriology immunoassay - other W0105011799 – 98/79 EUDAMED record Report an error
Chikungunya virus W0105040625 – 98/79 EUDAMED record Report an error
Coronavirus / influenza - RT & POC W0105090601 – 98/79 EUDAMED record Report an error
Dengue virus W0105040611 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402 – 98/79 EUDAMED record Report an error
IVD general use consumable devices - other W0599 A IVDR EUDAMED record Report an error
Mycobacterial detection by NA reagents W0105010703 – 98/79 EUDAMED record Report an error
Other virology controls - inf.imm. W0105080804 – 98/79 EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents W0105041003 – 98/79 EUDAMED record Report an error
Syphilis - RT & POC W0105090105 – 98/79 EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC W0105090502 – 98/79 EUDAMED record Report an error
D-dimer W0103020503 C IVDR, 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 antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Influenza & para influenza W0105040604 – 98/79 EUDAMED record Report an error
Leishmania W0105050205 – 98/79 EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC W0105099003 – 98/79 EUDAMED record Report an error
Multiple viruses - multiplex assays - other W0105070399 – 98/79 EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus W0105900101 – 98/79 EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents W0105070503 – 98/79 EUDAMED record Report an error
Salmonella antigen detection W0105011001 – 98/79 EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers- instruments W02010701 A IVDR EUDAMED record Report an error
Zika virus W0105040630 – 98/79 EUDAMED record Report an error
Bacteriology controls - inf.imm. W0105080801 – 98/79 EUDAMED record Report an error
Bordetella pertussis / parapertussis W0105011707 – 98/79 EUDAMED record Report an error
Brucella W0105011701 – 98/79 EUDAMED record Report an error
Chagas W0105050202 – 98/79 EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400) W0201010101 A IVDR EUDAMED record Report an error
Controls infectious immunology - RT & POC W0105094001 – 98/79 EUDAMED record Report an error
Dengue virus - NA reagents W0105040511 – 98/79 EUDAMED record Report an error
Enterovirus W0105040602 – 98/79 EUDAMED record Report an error
Flow cytometry instruments - other W02020499 A IVDR EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents W0105070504 – 98/79 EUDAMED record Report an error
Gonococcal antigen detection W0105010201 – 98/79 EUDAMED record Report an error
Hantavirus / bunyavirus W0105040614 – 98/79 EUDAMED record Report an error
Hav antibody (total) W0105020102 – 98/79 EUDAMED record Report an error
Hsv - NA reagents W0105040311 – 98/79 EUDAMED record Report an error
Hsv 1+2 igg W0105040303 – 98/79 EUDAMED record Report an error
Hsv 1+2 igm W0105040304 – 98/79 EUDAMED record Report an error
Monkeypox virus / mpox RT & POC W0105099008 – 98/79 EUDAMED record Report an error
Multiconstituent controls - inf.imm. W0105080807 – 98/79 EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other W02050199 – 98/79 EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents W0105070502 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) W0105040605 – 98/79 EUDAMED record Report an error
Samples collection devices - other accessories W050180 – 98/79 EUDAMED record Report an error
Tropical fever - multiplex NA reagents W0105070506 – 98/79 EUDAMED record Report an error
C.difficile by NA reagents W0105011804 – 98/79 EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection W0105011803 – 98/79 EUDAMED record Report an error
C.difficile GDH detection W0105011801 – 98/79 EUDAMED record Report an error
C.difficile toxin a/b detection W0105011802 – 98/79 EUDAMED record Report an error
Candida albicans W0105060302 – 98/79 EUDAMED record Report an error
Chlamydia trachomatis antigen detection W0105010107 – 98/79 EUDAMED record Report an error
Cryptococcus W0105060303 – 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007 – 98/79 EUDAMED record Report an error
Ebv - NA reagents W0105040403 – 98/79 EUDAMED record Report an error
Giardia lamblia W0105050208 – 98/79 EUDAMED record Report an error
Gonococcal detection by NA reagents W0105010203 – 98/79 EUDAMED record Report an error
Hav antibody igm W0105020104 – 98/79 EUDAMED record Report an error
Hav antigen confirmatory W0105020101 – 98/79 EUDAMED record Report an error
Hemostasis controls RT & POC W010302080501 – 98/79 EUDAMED record Report an error
Hev antibody igm W0105020505 – 98/79 EUDAMED record Report an error
HPV reagents - other W0105041099 – 98/79 EUDAMED record Report an error
Human metapneumovirus W0105040617 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Leptospira W0105011704 – 98/79 EUDAMED record Report an error
Lymphokines /immunmodulators - other W01030699 – 98/79 EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents W0105070505 – 98/79 EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent W0105040532 – 98/79 EUDAMED record Report an error
Multiple infectious - multiplex assays - other W0105070599 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays W0105010802 – 98/79 EUDAMED record Report an error
Mycoplasma antigen detection W0105010801 – 98/79 EUDAMED record Report an error
Mycoplasma pneumoniae detection by NA reagents W010501080301 – 98/79 EUDAMED record Report an error
Norovirus W0105040616 – 98/79 EUDAMED record Report an error
Other HPV - NA reagents W0105041005 – 98/79 EUDAMED record Report an error
Rotavirus W0105040606 – 98/79 EUDAMED record Report an error
Rsv - RT & POC W0105099002 – 98/79 EUDAMED record Report an error
Samples analyses, plastic microtubes - accessories W050301020280 – 98/79 EUDAMED record Report an error
Samples collection devices - other W05019099 – 98/79 EUDAMED record Report an error
Screening high-risk HPV - NA reagents W0105041002 – 98/79 EUDAMED record Report an error
Strep. a detection by NA reagents W0105011103 – 98/79 EUDAMED record Report an error
Streptococcal detection by NA reagents W0105011102 – 98/79 EUDAMED record Report an error
Toxoplasma antibody (total) W0105050101 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igg W0105050102 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 – 98/79 EUDAMED record Report an error
Trichomonas W0105050210 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699 – 98/79 EUDAMED record Report an error
Virology - NA reagents - other W0105040599 – 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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