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Emdyca

ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Clostridium difficile

EMDN code W01050118

64 manufacturers, 145 models including 142 on the market, 17 countries

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Manufacturers registered in Europe (EUDAMED) 64
  • 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
12 others
 B IVDR, 98/79 Website info@vitrosens.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
Hangzhou Laihe Biotech FDA EU representative : SUNGO Europe B.V. (Netherlands) China
2 others
 – 98/79 office@lyher.com EUDAMED record Report an error
R-Biopharm FDA Germany
1 other
 B IVDR, 98/79 Website EUDAMED record Report an error
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands) United States
1 other
 B IVDR, 98/79 Website EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States A IVDR, 98/79 Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Certest Spain B IVDR Website quality@certest.es 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 : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@rapidlabs.co.uk 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
Arcdia Finland – 98/79 Website office@arcdia.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website contact@diareagent.com EUDAMED record Report an error
gerbion Germany – 98/79 info@gerbion.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
bioMérieux FDA France B IVDR EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Clonit Italy – 98/79 Website info@clonit.it EUDAMED record Report an error
Diesse FDA Italy B IVDR Website EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website 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
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain) and 1 other China – 98/79 EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta) Canada – 98/79 Website support@pro-lab.com EUDAMED record Report an error
Progenie molecular S.L.U Spain – 98/79 EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain) China – 98/79 sale@rocgene.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
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea B IVDR, 98/79 Website EUDAMED record Report an error
Seramun Germany – 98/79 info@seramun.com EUDAMED record Report an error
Vircell Spain B IVDR EUDAMED record Report an error
Vitassay Spain – 98/79 Website info@vitassay.com EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands) United States B IVDR Website 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
Abacus Diagnostica Finland – 98/79 info@abacusdiagnostica.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
altona Diagnostics FDA Germany – 98/79 info@altona-diagnostics.com EUDAMED record Report an error
Anchor Diagnostics Germany – 98/79 info@anchor-diagnostics.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States B IVDR Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Bioeksen Türkiye – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
Cepheid FDA Sweden – 98/79 Website EUDAMED record Report an error
Cesna Türkiye B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 sales@coyotebio.com EUDAMED record Report an error
Dyonmed Greece – 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
ElitechGroup FDA Italy – 98/79 Website EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) 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
Idilbiotech Türkiye – 98/79 Website 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 CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China B IVDR marketing@hongweitest.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Serosep FDA Ireland – 98/79 Website info@serosep.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
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China B IVDR Website service@bioustar.com EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore – 98/79 Website infoAPAC@veladx.com EUDAMED record Report an error
Vitro FDA Romania B IVDR Website office@vitro.ro 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
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Uniogen No model still on the market Finland – 98/79 info@uniogen.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) 8

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
MARDX DIAGNOSTICS, INC. United States Trinity Biotech registered
Meridian Bioscience, Inc. Present in Europe in other categories United States ImmunoCard Toxins A & B PREMIER Toxins A and B K041003 (2004)
ACESO LABORATORIES INC. Present in Europe in other categories United States – registered
BBI Solutions OEM Limited United Kingdom – registered
EPITOPE DIAGNOSTICS, INC. United States – registered
First Light Diagnostics, Inc. United States – K193490 (2021)
MEDICAL CHEMICAL CORPORATION United States – registered
Scantibodies Laboratory Inc. United States – registered

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