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Emdyca

ReagentsInfectious diseasesMycology (infect. immunology/NAT)

Mycology immunoassays

EMDN code W01050603

39 manufacturers, 114 models including 114 on the market, 13 countries

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Manufacturers registered in Europe (EUDAMED) 39
  • 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
Dynamiker EU representative : Lotus NL B.V. (Netherlands) China
8 others
– 98/79 Website marketing@dynamiker.com EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Caretechion GmbH (Germany) China
7 others
– 98/79 Website marketing@era-bio.com EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
5 others
– 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
2 others
– 98/79 info@alltests.com.cn EUDAMED record Report an error
Vidia Czechia
1 other
– 98/79 Website EUDAMED record Report an error
TECOmedical EU representative : EUROBIO SCIENTIFIC (France) Switzerland – 98/79 Website info@tecomedical.com EUDAMED record Report an error
Vitrosens Türkiye C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Bio-Rad FDA France C IVDR Website contact@bio-rad.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
GaDia EU representative : ER Egészségügyi, Kereskedelmi és Szolgáltató Kft. (Hungary) Switzerland – 98/79 Website info@gadia.net EUDAMED record Report an error
Vircell Spain C IVDR, 98/79 EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States – 98/79 info@acrobiotech.com EUDAMED record Report an error
C-Luminary Biotechnology EU representative : Sungo Cert GmbH (Germany) China – 98/79 EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China – 98/79 info@biotests.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States – 98/79 quality@healgen.com EUDAMED record Report an error
Ldbio Diagnostics France – 98/79 Website EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 Website sales@limingbio.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Ravo Germany – 98/79 Website info@ravo.de EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United States B IVDR, 98/79 Website EUDAMED record Report an error
Tellgencorp EU representative : Medunion S.L. (Spain) China – 98/79 Website sales@tellgen.com EUDAMED record Report an error
Tianjin Jianbo Biological EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany) Russia – 98/79 Website EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 EUDAMED record Report an error
Biosynex France C IVDR Website reglementaire@biosynex.com EUDAMED record Report an error
Bordier FDA EU representative : Leman Diagnostics SARL (France) Switzerland – 98/79 Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Ecolidx Czechia – 98/79 Website EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Wako Chemicals Europe GmbH (Germany) Japan C IVDR 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
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 marketing@hongweitest.com EUDAMED record Report an error
Lab Diagnostic Systems (SMC) EU representative : SUNGO Europe B.V. (Netherlands) Pakistan – 98/79 info@ldspak.com EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China B IVDR Website EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website sales@syngenebio.com EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) C IVDR Website EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@rapidlabs.co.uk 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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