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Emdyca

Manufacturer

Gold Standard Diagnostics

Germany, United StatesLegal entities : Gold Standard Diagnostics Frankfurt GmbH, Gold Standard Diagnostics Kassel GmbH, Gold Standard Diagnostics, LLC

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

EU representative : Emergo Europe B.V. (Netherlands)

Website info.frankfurt@eu.goldstandarddiagnostics.com

76 categories, 298 models including 298 on the market, 2 countries

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CategoryEMDN codeRegistered modelsClassContact
Influenza & para influenza W0105040604
11 others
 – 98/79 EUDAMED record Report an error
Bordetella pertussis / parapertussis W0105011707
5 others
 – 98/79 EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc W0105900201
5 others
 A IVDR EUDAMED record Report an error
Coxiella burnetii (q fever) W0105011703
4 others
 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402
4 others
 – 98/79 EUDAMED record Report an error
Parasitology - other W0105050299
4 others
 – 98/79 EUDAMED record Report an error
Dengue virus W0105040611
2 others
 – 98/79 EUDAMED record Report an error
Tetanus (clostridium t.) W0105011709
2 others
 – 98/79 EUDAMED record Report an error
Adenovirus - NA reagents W0105040501
1 other
 – 98/79 EUDAMED record Report an error
Candida albicans W0105060302
1 other
 – 98/79 EUDAMED record Report an error
Diphtheria (corynebacterium d.) W0105011708
1 other
 – 98/79 EUDAMED record Report an error
Fsme virus W0105040612
1 other
 – 98/79 EUDAMED record Report an error
Mycoplasma antibody assays W0105010802
1 other
 – 98/79 EUDAMED record Report an error
Parvovirus b 19 W0105040609
1 other
 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) W0105040605
1 other
 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Rubella virus igg W0105040102 – 98/79 EUDAMED record Report an error
Zika virus W0105040630 – 98/79 EUDAMED record Report an error
Aspergillus W0105060301 – 98/79 EUDAMED record Report an error
Brucella W0105011701 – 98/79 EUDAMED record Report an error
Chikungunya virus W0105040625 – 98/79 EUDAMED record Report an error
Hantavirus / bunyavirus W0105040614 – 98/79 EUDAMED record Report an error
Hsv 1 igg W0105040306 – 98/79 EUDAMED record Report an error
Hsv 1 igm W0105040307 – 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
Hsv 2 igg W0105040309 – 98/79 EUDAMED record Report an error
Hsv 2 igm W0105040310 – 98/79 EUDAMED record Report an error
Legionella antibody assays W0105010502 – 98/79 EUDAMED record Report an error
Leptospira W0105011704 – 98/79 EUDAMED record Report an error
Measles virus igg W0105040702 – 98/79 EUDAMED record Report an error
Schistosoma W0105050206 – 98/79 EUDAMED record Report an error
Yersinia W0105011706 – 98/79 EUDAMED record Report an error
Chagas W0105050202 – 98/79 EUDAMED record Report an error
Chlamydia pneumoniae antibody iga W0105010114 – 98/79 EUDAMED record Report an error
Chlamydia pneumoniae antibody igg W0105010115 – 98/79 EUDAMED record Report an error
Chlamydia pneumoniae antibody igm W0105010116 – 98/79 EUDAMED record Report an error
Chlamydia trachomatis antibody iga W0105010109 – 98/79 EUDAMED record Report an error
Chlamydia trachomatis antibody igg W0105010110 – 98/79 EUDAMED record Report an error
Chlamydia trachomatis antibody igm W0105010111 – 98/79 EUDAMED record Report an error
Cmv igg W0105040203 – 98/79 EUDAMED record Report an error
Cmv igm W0105040204 – 98/79 EUDAMED record Report an error
Coronavirus igg W0105041103 – 98/79 EUDAMED record Report an error
Ebv vca igg W010504040105 – 98/79 EUDAMED record Report an error
Leishmania W0105050205 – 98/79 EUDAMED record Report an error
Measles virus igm W0105040703 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) W0105050209 – 98/79 EUDAMED record Report an error
Rubella virus igm W0105040103 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igg W0105050102 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igg - avidity W0105050104 – 98/79 EUDAMED record Report an error
Toxoplasma antibody igm W0105050103 – 98/79 EUDAMED record Report an error
Toxoplasma reagents - other W0105050199 – 98/79 EUDAMED record Report an error
Varicella zoster virus igg W0105040902 – 98/79 EUDAMED record Report an error
Varicella zoster virus igm W0105040903 – 98/79 EUDAMED record Report an error
Varicella zoster virus reagents - other W0105040999 – 98/79 EUDAMED record Report an error
Bacteriology immunoassay - other W0105011799 – 98/79 EUDAMED record Report an error
Cmv igg - avidity W0105040206 – 98/79 EUDAMED record Report an error
Cmv reagents - other W0105040299 – 98/79 EUDAMED record Report an error
Coronavirus iga W0105041105 – 98/79 EUDAMED record Report an error
Ebv antibodies - other W010504040199 – 98/79 EUDAMED record Report an error
Ebv ea igg W010504040108 – 98/79 EUDAMED record Report an error
Ebv ebna igg W010504040106 – 98/79 EUDAMED record Report an error
Ebv vca igm W010504040104 – 98/79 EUDAMED record Report an error
Echinococcus W0105050204 – 98/79 EUDAMED record Report an error
Entamoeba histolytica W0105050201 – 98/79 EUDAMED record Report an error
Infectious immunology instruments W0204 A IVDR EUDAMED record Report an error
Lyme antibody igg W0105010603 – 98/79 EUDAMED record Report an error
Lyme antibody igm W0105010604 – 98/79 EUDAMED record Report an error
Mumps / parotitis virus igg W0105040802 – 98/79 EUDAMED record Report an error
Mumps / parotitis virus igm W0105040803 – 98/79 EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents W0105040505 – 98/79 EUDAMED record Report an error
Syphilis reagents other W0105010399 C IVDR EUDAMED record Report an error
Coronavirus - NA reagents W0105041106 – 98/79 EUDAMED record Report an error
Hev antibody igg W0105020504 – 98/79 EUDAMED record Report an error
Hev antibody igm W0105020505 – 98/79 EUDAMED record Report an error
IVD general use consumables devices - other accessories W0580 A 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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