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Emdyca

ReagentsInfectious diseasesInfectious immunology - rapid tests & point of care

Controls, standards and calibrators infectious immunology - RT & POC

EMDN code W01050940

22 manufacturers, 410 models including 410 on the market, 12 countries

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Manufacturers registered in Europe (EUDAMED) 22
  • 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
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China
91 others
 – 98/79 Website info@kylinew.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
75 others
 – 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
71 others
 – 98/79 info@acrobiotech.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
56 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Biotical Spain
27 others
 – 98/79 Website EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain) China
7 others
 – 98/79 EUDAMED record Report an error
Vitrosens Türkiye
5 others
 C IVDR Website info@vitrosens.com EUDAMED record Report an error
Abbott FDA EU representative : MDSS GmbH (Germany) Germany, Japan
2 others
 – 98/79 Website EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain) China – 98/79 info@actest.com.cn EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France) France, Switzerland – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other United States – 98/79 quality@healgen.com EUDAMED record Report an error
Biolytical FDA EU representative : Emergo Europe B.V. (Netherlands) Canada – 98/79 EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Pluslife EU representative : Medunion S.L. (Spain) and 1 other China C IVDR, 98/79 Website ra@pluslife.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 EUDAMED record Report an error
R-Biopharm FDA Germany – 98/79 Website EUDAMED record Report an error
Biohit FDA Finland – 98/79 Website info@biohit.fi EUDAMED record Report an error
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 EUDAMED record Report an error
Roche FDA Germany B IVDR Website EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@sup-bio.com EUDAMED record Report an error
Tauns EU representative : Emergo Europe B.V. (Netherlands) Japan – 98/79 Website 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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