Skip to content
Emdyca

ReagentsInfectious diseasesHepatitis viruses (infect. immunology/NAT)

Hepatitis a virus

EMDN code W01050201

47 manufacturers, 103 models including 101 on the market, 10 countries

Export to CSV
Manufacturers registered in Europe (EUDAMED) 47
  • 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
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China
5 others
 – 98/79 EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Germany, South Korea
2 others
 B IVDR, 98/79 Website 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
Denizbiyokimya Türkiye
1 other
 – 98/79 EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) United States B IVDR, 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 EUDAMED record Report an error
Vitrosens Türkiye C 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 – 98/79 info@alltests.com.cn 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
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
Aichek FDA EU representative : Medunion S.L. (Spain) China – 98/79 ra.rep@aichek.com 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 Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium) China – 98/79 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
bioMérieux FDA France B IVDR EUDAMED record Report an error
DiaSorin FDA Italy B IVDR, 98/79 Website EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@genesignbio.com 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
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@huiantech.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States B IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) 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
altona Diagnostics FDA Germany C IVDR info@altona-diagnostics.com EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) China B IVDR Website contact@diareagent.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Clonit Italy – 98/79 Website info@clonit.it EUDAMED record Report an error
Core Technology FDA 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
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
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH Germany – 98/79 Website info@gfeblut.de 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
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) China B IVDR Website 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
Sansure FDA EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn 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
Tianjin Bioscience Diagnostic Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium) China – 98/79 Website sales@wondfo.com.cn 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
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market China – 98/79 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
Roche Diagnostics Corp. Present in Europe in other categories United States Elecsys Anti-HAV II Elecsys AntiHAV Assay Elecsys AntiHAV IgM Elecsys Anti-HAV IgM Elecsys Anti-HAV K260048 (2026)
Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories United States VITROS K060770 (2006)
Bio-Rad Present in Europe in other categories United States MONOLISA K092355 (2009)
Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories France – registered
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Diamond Diagnostics Inc. Present in Europe in other categories United States – registered
QuidelOrtho Corporation United States – registered
Roche Diagnostics Operations Inc. United States – registered

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Related categories