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Emdyca

ReagentsInfectious diseasesMultiple parameters - (infect. immunology/NAT)

Multiple panels for infections - various

EMDN code W01050705

110 manufacturers, 967 models including 953 on the market, 20 countries

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Manufacturers registered in Europe (EUDAMED) 110
  • 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
Vitrosens Türkiye
126 others
 B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other Australia
76 others
 – 98/79 Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Idilbiotech Türkiye
61 others
 – 98/79 Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
47 others
 B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
26 others
 B, C IVDR, 98/79 Website info@seegene.com EUDAMED record Report an error
Bioeksen Türkiye
22 others
 – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
gerbion Germany
21 others
 – 98/79 info@gerbion.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye
20 others
 – 98/79 Website EUDAMED record Report an error
Poly Diagnostics Luxembourg
20 others
 B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye
16 others
 C IVDR, 98/79 Website info@anatoliagenetik.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China
16 others
 – 98/79 EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
14 others
 C IVDR, 98/79 Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States
14 others
 – 98/79 quality@healgen.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China
14 others
 C IVDR, 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
13 others
 – 98/79 EUDAMED record Report an error
Certest Spain
11 others
 B, C IVDR, 98/79 Website quality@certest.es EUDAMED record Report an error
Vitassay Spain
11 others
 – 98/79 Website info@vitassay.com EUDAMED record Report an error
Cesna Türkiye
10 others
 B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Ecolidx Czechia
7 others
 – 98/79 Website EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea
6 others
 – 98/79 EUDAMED record Report an error
Vircell Spain
6 others
 B, C IVDR, 98/79 EUDAMED record Report an error
ElitechGroup FDA Italy
5 others
 B, C IVDR, 98/79 Website EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India
5 others
 – 98/79 Website EUDAMED record Report an error
Immundiagnostik FDA Germany
5 others
 – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China
5 others
 B, C IVDR, 98/79 Website service@bioustar.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China
4 others
 – 98/79 Website EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
4 others
 – 98/79 info@flash-dx.com EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain) China
4 others
 B IVDR, 98/79 EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain) China
4 others
 – 98/79 EUDAMED record Report an error
bioMérieux FDA France
3 others
 B IVDR, 98/79 EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea
3 others
 – 98/79 Website info@kogene.co.kr EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France) United States
2 others
 B, C, D IVDR EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
2 others
 – 98/79 Website EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
2 others
 – 98/79 EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 1 other China
2 others
 – 98/79 EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium) South Korea
1 other
 B, C IVDR Website ra@genetree.co.kr EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 – 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States
1 other
 B, C IVDR EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 2 others China
1 other
 – 98/79 EUDAMED record Report an error
R-Biopharm FDA Germany
1 other
 C IVDR, 98/79 Website EUDAMED record Report an error
Serosep FDA Ireland – 98/79 Website info@serosep.com EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany) Australia
1 other
 – 98/79 Website RAQA@geneticsignatures.com EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland) India C IVDR Website info@3bblackbio.com EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@am-diagnostics.co.uk EUDAMED record Report an error
altona Diagnostics FDA Germany B, C IVDR info@altona-diagnostics.com EUDAMED record Report an error
Eurobio Scientific France – 98/79 reglementaire@eurobio-scientific.com EUDAMED record Report an error
Hain Lifescience Germany C IVDR, 98/79 EUDAMED record Report an error
Hybribio EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other China – 98/79 EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) 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
Pilotgene EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Progenie molecular S.L.U Spain – 98/79 EUDAMED record Report an error
Ademtech France B IVDR Website EUDAMED record Report an error
Beijing OriginPoly Bio-Tec EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Geneproof Czechia C IVDR, 98/79 Website support@geneproof.com EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China C IVDR, 98/79 support@igenesisbio.com EUDAMED record Report an error
Kingcreate EU representative : Kingsmead Service B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Qiagen FDA Germany C IVDR, 98/79 Website info@qiagen.com EUDAMED record Report an error
Vitro FDA Spain C IVDR Website regulatory@vitro.bio EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Ablsa Luxembourg – 98/79 Website contact@ablsa.com EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) Singapore – 98/79 Website EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Biosynex France C IVDR Website reglementaire@biosynex.com EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden) Sweden, United States B IVDR, 98/79 Website EUDAMED record Report an error
Elisabeth Czechia – 98/79 Website info@elisabeth.cz EUDAMED record Report an error
Guangzhou Biotron Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : VidaQuick Biotech S.L. (Spain) China – 98/79 info@alltests.com.cn EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Luminex Molecular Diagnostics FDA EU representative : DiaSorin Italia S.p.A. (Italy) Canada B IVDR, 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
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
PentaBase Denmark – 98/79 Website info@pentabase.com 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
Targetingone EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other China – 98/79 Website sales@tellgen.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Wells Bio EU representative : MDSS GmbH (Germany) South Korea – 98/79 Website info@wellsbio.net EUDAMED record Report an error
-Diagnostics EU representative : mdi Europa GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) United States C IVDR EUDAMED record Report an error
Appolon Bioteck France C IVDR Website contact@appolonbioteck.com EUDAMED record Report an error
Atlas Link Technology FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) China C IVDR Website 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
Bioperfectus FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR EUDAMED record Report an error
Clonit Italy – 98/79 Website info@clonit.it EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 service@credodxbiomed.com 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
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain) China – 98/79 Website marketing@dynamiker.com EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de 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
Genemind EU representative : Medunion S.L. (Spain) China – 98/79 regulatoryaffairs@genemind.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China C IVDR EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) China C IVDR office@lyher.com 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
Molbio Diagnostics EU representative : QbD RepS BV (Belgium) India C IVDR Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Operon FDA Spain – 98/79 Website infoeudamed@operon.es EUDAMED record Report an error
OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China – 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR Website EUDAMED record Report an error
SpeeDx FDA EU representative : MedEnvoy Global BV (Netherlands) Australia C IVDR Website regulatory@speedx.com.au EUDAMED record Report an error
Suny (Xiamen) Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium) China – 98/79 Website EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium) China C IVDR PMS@zy-ivd.com EUDAMED record Report an error
Mobidiag No model still on the market Finland
2 others
 – 98/79 Website sales.mob@hologic.com EUDAMED record Report an error
Arcdia No model still on the market Finland A IVDR Website office@arcdia.com EUDAMED record Report an error
Raingene EU representative : Lotus NL B.V. (Netherlands) No model still on the market China – 98/79 EUDAMED record Report an error
Innobiochips No model still on the market France – 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.

Other manufacturers known in the United States (FDA) 3

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)

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