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Emdyca

Manufacturer

Vivachek

ChinaLegal entities : VivaChek Biotech (Hangzhou) Co., Ltd.

First countries of placing on the market declared in EUDAMED : Austria, Croatia, Czechia, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Türkiye

EU representative : Lotus NL B.V. (Netherlands)

info@vivachek.com

44 categories, 181 models including 180 on the market, 1 country

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CategoryEMDN codeRegistered modelsClassContact
Virology - RT & POC - other W0105099099
37 others
 – 98/79 EUDAMED record Report an error
Blood glucose meters W0201060102
23 others
 A IVDR, 98/79 EUDAMED record Report an error
Bacteriology - RT & POC - other W0105090199
8 others
 – 98/79 EUDAMED record Report an error
Viral antigen/antibody detection - other W0105040699
4 others
 – 98/79 EUDAMED record Report an error
Dengue - RT & POC W0105099007
1 other
 – 98/79 EUDAMED record Report an error
Hepatitis viruses - RT & POC - other W0105090299
1 other
 – 98/79 EUDAMED record Report an error
Plasmodium (malaria) - RT & POC W0105090401
1 other
 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) W0201020102 A IVDR EUDAMED record Report an error
H. pylori - RT & POC W0105090102 – 98/79 EUDAMED record Report an error
Parasites - RT & POC - other W0105090499 – 98/79 EUDAMED record Report an error
Strep. a - RT & POC W0105090103 – 98/79 EUDAMED record Report an error
Syphilis - RT & POC W0105090105 – 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
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents W0105070304 – 98/79 EUDAMED record Report an error
Other multiple pathogens - RT & POC W0105090699 – 98/79 EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC W0105090106 – 98/79 EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC W0105090502 – 98/79 EUDAMED record Report an error
D-dimer - RT & POC W0103020803 – 98/79 EUDAMED record Report an error
Hsv 1 igg W0105040306 – 98/79 EUDAMED record Report an error
Influenza a and /or b - RT & POC W0105099004 – 98/79 EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC W0105099003 – 98/79 EUDAMED record Report an error
Strep. pneumoniae - RT & POC W0105090109 – 98/79 EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other W0201069099 – 98/79 EUDAMED record Report an error
Adenovirus W0105040601 – 98/79 EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h) W0201020101 A IVDR EUDAMED record Report an error
Chemistry analysers - IVD medical device software W0201010192 A IVDR EUDAMED record Report an error
Ebv antibodies - other W010504040199 – 98/79 EUDAMED record Report an error
Glycosilated hemoglobin devices W0201060101 A IVDR EUDAMED record Report an error
Gonococcal antigen detection W0105010201 – 98/79 EUDAMED record Report an error
H. pylori antibody assays W0105010402 – 98/79 EUDAMED record Report an error
H. pylori antigen detection W0105010401 – 98/79 EUDAMED record Report an error
Haematology controls - RT & POC W0103010606 – 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
Infectious immunology - other W0105900299 – 98/79 EUDAMED record Report an error
Interleukin 6 (il-6) W01030609 – 98/79 EUDAMED record Report an error
Legionella - RT & POC W0105090108 – 98/79 EUDAMED record Report an error
Prothrombin time ( quick test ) W0103020101 – 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
Strep. b - RT & POC W0105090104 – 98/79 EUDAMED record Report an error
Various diabetes monitoring instruments - other W020106019099 A IVDR EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800) No model still on the market W0201010102 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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