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Emdyca

Infectious diseasesMultiple parameters - (infect. immunology/NAT)Multiple panels for infections - various

Gastrointestinal infections - multiplex NA reagents

EMDN code W0105070504

52 manufacturers, 193 models including 190 on the market, 16 countries

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Manufacturers registered in Europe (EUDAMED) 52
  • 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
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other Australia
15 others
 – 98/79 Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Vitrosens Türkiye
15 others
 B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Idilbiotech Türkiye
9 others
 – 98/79 Website EUDAMED record Report an error
Poly Diagnostics Luxembourg
9 others
 B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
4 others
 B, C IVDR, 98/79 Website info@seegene.com EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain) China
4 others
 – 98/79 EUDAMED record Report an error
Bioeksen Türkiye
2 others
 – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China
1 other
 – 98/79 EUDAMED record Report an error
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Serosep FDA Ireland – 98/79 Website info@serosep.com EUDAMED record Report an error
Cesna Türkiye B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany) Australia – 98/79 Website RAQA@geneticsignatures.com EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium) South Korea B, C IVDR Website ra@genetree.co.kr EUDAMED record Report an error
gerbion Germany – 98/79 info@gerbion.com EUDAMED record Report an error
R-Biopharm FDA Germany C IVDR, 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
Ademtech France B IVDR Website EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website ra_oversea@bioer.com.cn EUDAMED record Report an error
ElitechGroup FDA Italy B IVDR Website EUDAMED record Report an error
Vircell Spain B IVDR EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France) United States B IVDR EUDAMED record Report an error
Certest Spain B IVDR Website quality@certest.es EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@flash-dx.com EUDAMED record Report an error
Hain Lifescience Germany C IVDR 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
Hologic FDA EU representative : Hologic BV (Belgium) United States C IVDR EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea – 98/79 EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website info@kogene.co.kr EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Rapid Labs EU representative : VidaQuick Biotech S.L. (Spain) United Kingdom (ex Northern Ireland) – 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain) China – 98/79 sale@rocgene.com 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
Biosynex France C IVDR Website reglementaire@biosynex.com EUDAMED record Report an error
Cepheid FDA Sweden B IVDR Website EUDAMED record Report an error
GeneMatrix EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website support@genematrix.net 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 C IVDR EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 support@igenesisbio.com EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China – 98/79 EUDAMED record Report an error
Luminex Molecular Diagnostics FDA EU representative : DiaSorin Italia S.p.A. (Italy) Canada – 98/79 Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States C IVDR Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Qiagen FDA Germany C IVDR, 98/79 Website info@qiagen.com 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
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain) China – 98/79 EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China B IVDR, 98/79 Website service@bioustar.com EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye B IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Mobidiag No model still on the market Finland – 98/79 Website sales.mob@hologic.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.

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
Becton, Dickinson & CO Present in Europe in other categories United States BD MAX™ Enteric Viral Panel BD Enteric Bacterial Panel for BD COR™ System BD MAX™ Enteric Parasite Panel BD MAX™ Extended Enteric Bacterial Panel BD Enteric Bacterial Panel plus for BD COR™ System BD MAX™ Enteric Bacterial Panel K220607 (2022)
APPLIED BIOCODE, INC. United States Gastrointestinal Pathogen Panel (GPP) Kit BioCode MDx 3000 K242877 (2025)
GREAT BASIN SCIENTIFIC, INC. United States Shiga Toxin Direct Test Stool Bacterial Pathogens Panel K152955 (2016)
bioMerieux, Inc. Present in Europe in other categories United States – registered

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