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Bacteriology (infect. immunology/NAT)Mycoplasma / ureaplasmaMycoplasma / ureaplasma detection by NA reagents

Mycoplasma pneumoniae detection by NA reagents

EMDN code W010501080301

16 manufacturers, 30 models including 21 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 16
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Vitrosens Türkiye B IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Vircell Spain B, C IVDR EUDAMED record Report an error
Geneproof Czechia – 98/79 Website support@geneproof.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany) China B IVDR Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Elisabeth Czechia – 98/79 Website info@elisabeth.cz EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Canada – 98/79 sales@orientgene.com EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 marketing@hongweitest.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Pluslife EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 Website ra@pluslife.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China C IVDR Website service@bioustar.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye B IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China
4 others
 – 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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