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Emdyca

Infectious diseasesBacteriology (infect. immunology/NAT)Streptococci

Strep. b detection by NA reagents

EMDN code W0105011104

26 manufacturers, 32 models including 31 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 26
  • 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 C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Hybribio EU representative : Kingsmead Service B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States C IVDR Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Bioeksen Türkiye – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden) Sweden, United States C IVDR, 98/79 Website EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 sales@coyotebio.com EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States – 98/79 Website ivdr_dsm@diasorin.com EUDAMED record Report an error
Eurobio Scientific France – 98/79 reglementaire@eurobio-scientific.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 info@alltests.com.cn 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
Hologic FDA EU representative : Hologic BV (Belgium) United States C IVDR EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States C IVDR Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China C IVDR, 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website info@tibchina.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore – 98/79 Website infoAPAC@veladx.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium) China – 98/79 Website EUDAMED record Report an error
Biosynex No model still on the market France C IVDR Website reglementaire@biosynex.com 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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