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Emdyca

Infectious diseasesParasitology (infect. immunology/NAT)Miscellaneous parasitology immunoassay

Plasmodium (malaria)

EMDN code W0105050209

44 manufacturers, 106 models including 99 on the market, 10 countries

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Manufacturers registered in Europe (EUDAMED) 44
  • 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
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States – 98/79 info@acrobiotech.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@cybereagen.com EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany) and 1 other China C IVDR Website info@diagreat.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
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium) India – 98/79 Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website info@realytech.com EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany) China – 98/79 sales@syngenebio.com EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland) United States – 98/79 Website EUDAMED record Report an error
Eiken FDA EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany) Japan C IVDR regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com 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
Wondfo FDA EU representative : QbD RepS BV (Belgium) China – 98/79 Website sales@wondfo.com.cn 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
Clonit Italy – 98/79 Website info@clonit.it EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Genekam Germany – 98/79 Website office@genekam.de EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website info@khmedical.co.kr EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye – 98/79 Website info@anatoliagenetik.com EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@anbio.com EUDAMED record Report an error
Bioeksen Türkiye – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
Biosynex France – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Cytecs Germany – 98/79 Website info@cytecs.com EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@jgbiotech.com EUDAMED record Report an error
Hightopbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website 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
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China – 98/79 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
Noul FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website cs@noul.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website service@bioustar.com EUDAMED record Report an error
Vitrosens Türkiye – 98/79 Website info@vitrosens.com EUDAMED record Report an error
Biotime EU representative : Medunion S.L. (Spain) No model still on the market China – 98/79 EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : MedNet EC-REP GmbH (Germany) No model still on the market China – 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.

Other manufacturers known in the United States (FDA) 4

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
CLARK LABORATORIES, INC. United States Trinity Biotech Bio-Rad registered
Alere Scarborough, Inc. United States BinaxNOW® Malaria registered
NANO-DITECH CORPORATION United States Nano-CheckTM Malaria registered
Abbott Laboratories Present in Europe in other categories United States – registered

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