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Emdyca

Infectious diseasesBacteriology (infect. immunology/NAT)Helicobacter pylori

H. pylori antigen detection

EMDN code W0105010401

69 manufacturers, 129 models including 128 on the market, 11 countries

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Manufacturers registered in Europe (EUDAMED) 69
  • 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
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) China
8 others
 – 98/79 sales@dbluemedical.com EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
2 others
 – 98/79 Website export@keyubio.com EUDAMED record Report an error
Biocare Medical EU representative : Emergo Europe B.V. (Netherlands) United States
1 other
 – 98/79 Website EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) China
1 other
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States – 98/79 info@acrobiotech.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (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
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
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website marketing@boditech.co.kr 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
Diagreat EU representative : MedNet EC-REP GmbH (Germany) and 1 other China B IVDR Website info@diagreat.com EUDAMED record Report an error
Diesse FDA Italy B IVDR Website EUDAMED record Report an error
Eurospital FDA Italy – 98/79 regulatory@eurospital.it EUDAMED record Report an error
Genesignbio EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 info@genesignbio.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China B IVDR, 98/79 EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 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 Website EUDAMED record Report an error
R-Biopharm FDA Germany B IVDR Website EUDAMED record Report an error
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany) China – 98/79 EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@anbio.com EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 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
Beijing Kewei Clinical Diagnostic Reagent EU representative : Lotus NL B.V. (Netherlands) China – 98/79 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
Biomerica FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website info@biomerica.com EUDAMED record Report an error
Campmedica Romania – 98/79 Website EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany) United States B IVDR Website info@ctkbiotech.com EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain) China – 98/79 Website EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States – 98/79 Website ivdr_dsu@diasorin.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
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com EUDAMED record Report an error
Fortress Diagnostics Northern Ireland – 98/79 Website info@fortressdiagnostics.com EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@biotests.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
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) China B IVDR office@lyher.com EUDAMED record Report an error
Hangzhou New Horizon Health Technology EU representative : MedPath GmbH (Germany) and 1 other China C IVDR, 98/79 Website compliance@nhbio.com.cn EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
IBL International Germany – 98/79 Website EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : SUNGO Europe B.V. (Netherlands) 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
Nanjing Synthgene Medical Technology FDA EU representative : MedPath GmbH (Germany) China C IVDR Website sales@syngenebio.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea B IVDR Website EUDAMED record Report an error
Seramun Germany – 98/79 info@seramun.com EUDAMED record Report an error
Shenzhen Freecom Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website sales@szzijian.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
Vircell Spain B IVDR EUDAMED record Report an error
Vitro FDA Romania B IVDR Website office@vitro.ro EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website info@wwhsbio.com EUDAMED record Report an error
Zetmedikal Türkiye – 98/79 Website info@zetmedikal.com EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) No model still on the market China – 98/79 qa@egens-bio.cn 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.

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