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Emdyca

ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Helicobacter pylori

EMDN code W01050104

118 manufacturers, 330 models including 325 on the market, 22 countries

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Manufacturers registered in Europe (EUDAMED) 118
  • 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
15 others
 – 98/79 sales@dbluemedical.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
9 others
 – 98/79 Website info@testlinecd.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
7 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Monobind FDA EU representative : AR Experts B.V. (Netherlands) United States
7 others
 – 98/79 Website info@monobind.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
6 others
 – 98/79 info@acrobiotech.com EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
4 others
 – 98/79 Website info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other China
4 others
 B IVDR, 98/79 office@lyher.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China
3 others
 – 98/79 Website 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
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
2 others
 – 98/79 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
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@cybereagen.com EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de 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
Seramun Germany – 98/79 info@seramun.com EUDAMED record Report an error
Vircell Spain B IVDR, 98/79 EUDAMED record Report an error
Bgi Denmark – 98/79 Website EUDAMED record Report an error
Diesse FDA Italy B, C IVDR Website EUDAMED record Report an error
IBL International Germany – 98/79 Website EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China – 98/79 Website 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
Mikrogen Germany – 98/79 EUDAMED record Report an error
R-Biopharm FDA Germany B IVDR, 98/79 Website EUDAMED record Report an error
Vitrosens Türkiye B IVDR, 98/79 Website info@vitrosens.com 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
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye – 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
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 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
Diagreat EU representative : MedNet EC-REP GmbH (Germany) and 1 other China B, C IVDR Website info@diagreat.com EUDAMED record Report an error
Fortress Diagnostics Northern Ireland – 98/79 Website info@fortressdiagnostics.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
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Kamiya Biomedical FDA EU representative : Advena Limited (Malta) United States – 98/79 Website info@k-assay.com EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti Türkiye B IVDR, 98/79 Website info@koroglugroup.com EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website sales@szzijian.com EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland) United States – 98/79 Website EUDAMED record Report an error
Viramed FDA Germany B IVDR Website 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
Anbio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@anbio.com EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com 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
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website marketing@boditech.co.kr 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
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States – 98/79 Website ivdr_dsu@diasorin.com 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
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Human Germany – 98/79 Website EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Labsystems Diagnostics FDA Finland – 98/79 Website EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany) Singapore – 98/79 EUDAMED record Report an error
Orgentec Germany – 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
Sansure FDA EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Sanymed Italy – 98/79 Website info@sanymed.it 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
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
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (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
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany) Russia – 98/79 Website EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany) China – 98/79 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
Aichek FDA EU representative : Medunion S.L. (Spain) China – 98/79 ra.rep@aichek.com EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website 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 Kewei Clinical Diagnostic Reagent EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Bioeksen Türkiye – 98/79 Website info@bioeksen.com.tr 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
Biohit FDA Finland – 98/79 Website info@biohit.fi EUDAMED record Report an error
bioMérieux FDA France C IVDR EUDAMED record Report an error
Bosonbio FDA EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Campmedica Romania – 98/79 Website EUDAMED record Report an error
Certest Spain B IVDR Website quality@certest.es EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain) China – 98/79 Website EUDAMED record Report an error
Diagnostics Belgium – 98/79 Website 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
Dyonmed Greece – 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
Ecolidx Czechia – 98/79 Website EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website ra@genetree.co.kr EUDAMED record Report an error
Hain Lifescience Germany – 98/79 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 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
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
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Ingenetix Austria – 98/79 Website office@ingenetix.com 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
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
Poly Diagnostics Luxembourg B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Ravo Germany – 98/79 Website info@ravo.de 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
Shenzhen Freecom Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 Website info@orienterglobal.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United Kingdom (ex Northern Ireland) B IVDR Website contact@siemens-healthineers.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
Vitassay Spain – 98/79 Website info@vitassay.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
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain) China – 98/79 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) and 1 other No model still on the market China – 98/79 qa@egens-bio.cn EUDAMED record Report an error
Princeton BioMeditech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market United States – 98/79 Website info@pbmc.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) 45

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
Meridian Bioscience, Inc. Present in Europe in other categories United States PREMIER H. pylori Curian Analyzer ImmunoCard STAT! HpSA ImmunoCard H. pylori Curian HpSA PREMIER Platinum HpSA PLUS K230901 (2023)
MARDX DIAGNOSTICS, INC. United States Trinity Biotech registered
ALFA SCIENTIFIC DESIGNS, INC. United States INSTANT-VIEW H. Pylori Serum Cassette Test INSTANT-VIEW H. pylori Rapid Test INSTANT-VIEW H. Pylori Whole Blood/Serum Cassette Test K024360 (2003)
MCKESSON MEDICAL-SURGICAL INC. – McKesson registered
Quest Intl., Inc. United States ReQuest SeraQuest registered
CLARK LABORATORIES, INC. United States Trinity Biotech registered
Cardinal Health 200, LLC Present in Europe in other categories United States CARDINAL HEALTH registered
Gi Supply United States HpFast Urease HpOne K012411 (2001)
HENRY SCHEIN, INC. Present in Europe in other categories United States Henry Schein registered
Immunostics Company, Inc United States Detector H. pylori registered
Inova Diagnostics, Inc. Present in Europe in other categories United States QUANTA Lite® H.pylori IgG ELISA QUANTA Lite® H.pylori IgA ELISA K024334 (2003)
JANT PHARMACAL CORPORATION – ACCUTEST H. Pylori Rapid Test Device (Whole Blood/Serum) *CLIA-Waived* Accutest H. Pylori Urease Rapid Test registered
Quidel Corp. United States QuickVue K991747 (1999)
TECO DIAGNOSTICS United States Teco Diagnostics H. Pylori Card Test registered
Arj Medical, Inc. Present in Europe in other categories United States PyloPlus+ Rapid Urease Test K052708 (2006)
BTNX Inc – Rapid Response registered
Beckman Coulter, Inc. Present in Europe in other categories United States Icon registered
Diagnostic Automation, Inc. – AccuDiag ™ registered
Diamedix Corp. United States Diamedix registered
Fisher Scientific Co., LLC United States Sure-Vue registered
GERMAINE LABORATORIES, INC United States AIMSTEP H. PYLORI registered
HARDY DIAGNOSTICS United States QwikID registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States MEDLINE registered
MedMira Laboratories Inc Canada MedMira Rapid H. Pylori Antibody Test K002023 (2000)
NATIONAL DISTRIBUTION & CONTRACTING, INC. – PRO ADVANTAGE registered
Polymedco, Inc. United States Poly stat registered
Remel Co. Present in Europe in other categories United States REMEL K883641 (1989)
Sekisui Diagnostics, LLC Present in Europe in other categories United States OSOM H Pylori 25 Test Kit registered
Serim Research Corp. United States Serim® PyloriTek® Test Kit K014038 (2002)
Avanos Medical, Inc. United States – registered
Axxin Pty Ltd Australia – registered
BIOCHECK, INC. United States – registered
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Diamond Diagnostics Inc. Present in Europe in other categories United States – registered
Instrumentation Laboratory CO Present in Europe in other categories United States – registered
Kenlor Industries, Inc. United States – K964014 (1997)
LUMIQUICK DIAGNOSTICS, INC. United States – registered
Micro Detect, Inc. United States – K003794 (2001)
OPERON, S.A. Present in Europe in other categories Spain – registered
Panion & BF Biotech, Inc. Taiwan – K183573 (2019)
SST International Inc. United States – registered
Sanicure BV Netherlands – registered
Scantibodies Laboratory Inc. United States – registered
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories United States – registered
Zeus Scientific, Inc. Present in Europe in other categories United States – K991820 (1999)

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