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Emdyca

ReagentsInfectious diseasesParasitology (infect. immunology/NAT)

Miscellaneous parasitology immunoassay

EMDN code W01050502

72 manufacturers, 302 models including 292 on the market, 16 countries

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Manufacturers registered in Europe (EUDAMED) 72
  • 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
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
18 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
12 others
 – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Vitrosens Türkiye
12 others
 B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
8 others
 – 98/79 info@acrobiotech.com EUDAMED record Report an error
Euroimmun FDA Germany
8 others
 B IVDR, 98/79 Website info@euroimmun.de EUDAMED record Report an error
Vircell Spain
6 others
 – 98/79 EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
4 others
 – 98/79 Website EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
3 others
 – 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Bordier FDA EU representative : Leman Diagnostics SARL (France) Switzerland
2 others
 B IVDR, 98/79 Website EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States
2 others
 – 98/79 quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
2 others
 – 98/79 EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany) China
1 other
 – 98/79 sales@accubiotech.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) China
1 other
 – 98/79 EUDAMED record Report an error
Clonit Italy
1 other
 – 98/79 Website info@clonit.it EUDAMED record Report an error
Ldbio Diagnostics France
1 other
 – 98/79 Website EUDAMED record Report an error
R-Biopharm FDA Germany
1 other
 B IVDR, 98/79 Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 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
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
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 Website 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
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@jgbiotech.com 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
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website sales@syngenebio.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
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland) United States – 98/79 Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other China – 98/79 office@guoke-medical.com 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
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
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website info@khmedical.co.kr EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) B IVDR, 98/79 Website EUDAMED record Report an error
Seramun Germany – 98/79 info@seramun.com EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain) China – 98/79 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 : QbD RepS BV (Belgium) China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website EUDAMED record Report an error
Genekam Germany – 98/79 Website office@genekam.de EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website export@keyubio.com EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Argentina – 98/79 Website marketing@wiener-lab.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Dutch Diagnostics Netherlands – 98/79 Website info@dutch-diagnostics.com EUDAMED record Report an error
Elitech Microbio France B IVDR 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
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Hightopbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
IBL International Germany – 98/79 Website EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.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
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China – 98/79 EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 Website sales@limingbio.com EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China – 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
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
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany) Russia – 98/79 Website 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
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) 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) 11

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
DRG Instruments Gesellschaft mit beschränkter Haftung – Entamoeba histolytica IgG ELISA registered
DRG International Inc United States E. Histolytica IgG ELISA Entamoeba histolytica IgG ELISA registered
Biomerica, Inc. Present in Europe in other categories United States E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] registered
Diagnostic Automation, Inc. – AccuDiag ™ registered
NANO-DITECH CORPORATION United States Nano-CheckTM Malaria registered
ACESO LABORATORIES INC. Present in Europe in other categories United States – registered
BIOCHECK, INC. United States – registered
Eiger Diagnostics, Inc. United States – registered
New Life Diagnostics. Inc. United States – registered

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