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Emdyca

ReagentsInfectious diseases

Hepatitis viruses (infect. immunology/NAT)

EMDN code W010502

83 manufacturers, 319 models including 314 on the market, 18 countries

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Manufacturers registered in Europe (EUDAMED) 83
  • 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
Denizbiyokimya Türkiye
19 others
 – 98/79 EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : SUNGO Europe B.V. (Netherlands) China
9 others
 – 98/79 office@lyher.com EUDAMED record Report an error
Vitrosens Türkiye
8 others
 C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China
7 others
 – 98/79 EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) and 1 other Germany, Ireland, South Korea, United States
5 others
 B, C, D IVDR, 98/79 Website EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States
5 others
 B, D IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
4 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) United States
3 others
 B IVDR, 98/79 Website EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium) China
3 others
 – 98/79 EUDAMED record Report an error
Idilbiotech Türkiye
2 others
 – 98/79 Website EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United Kingdom (ex Northern Ireland)
2 others
 C, D IVDR, 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany) Taiwan
2 others
 – 98/79 sales.group@gbc.com.tw EUDAMED record Report an error
Diagnostic Systems Germany
1 other
 – 98/79 Website info@ab-ds.de EUDAMED record Report an error
Mikrogen Germany
1 other
 B, C IVDR, 98/79 EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China
1 other
 – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
1 other
 – 98/79 Website EUDAMED record Report an error
Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium) India D IVDR, 98/79 Website ram.kanoje@merillife.com EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C, D IVDR 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
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
altona Diagnostics FDA Germany C IVDR, 98/79 info@altona-diagnostics.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
bioMérieux FDA France B, C IVDR EUDAMED record Report an error
Diapro Italy – 98/79 Website info@diapro.it EUDAMED record Report an error
DiaSorin FDA Italy B, C IVDR, 98/79 Website EUDAMED record Report an error
Ecolidx Czechia – 98/79 Website 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
Innodx EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR, 98/79 Website EUDAMED record Report an error
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi Türkiye – 98/79 Website EUDAMED record Report an error
Vircell Spain B, C, D IVDR EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China – 98/79 Website 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
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye D IVDR, 98/79 Website info@anatoliagenetik.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye – 98/79 Website EUDAMED record Report an error
Biolytical FDA EU representative : Emergo Europe B.V. (Netherlands) Canada – 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
ElitechGroup FDA Italy D IVDR, 98/79 Website EUDAMED record Report an error
Geneproof Czechia – 98/79 Website support@geneproof.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
Iontek Türkiye – 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
Roboscreen Germany – 98/79 Website info@roboscreen.com EUDAMED record Report an error
Adaltis Italy – 98/79 Website info@adaltis.net 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
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) 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
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea D IVDR Website sales@bioneer.com EUDAMED record Report an error
Clonit Italy – 98/79 Website info@clonit.it EUDAMED record Report an error
Dialab Austria – 98/79 Website office@dialab.at EUDAMED record Report an error
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Fujirebio FDA Belgium C IVDR Website EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@genesignbio.com EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States D IVDR EUDAMED record Report an error
Nuclear Laser Medicine Italy C IVDR Website quality@nlm.it EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Raritan EU representative : Ortho-Clinical Diagnostics France (France) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Qiagen FDA Germany – 98/79 Website info@qiagen.com 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
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@huiantech.com 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
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Ab Analitica Italy C IVDR customersupport@abanalitica.it 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
Bio-Rad FDA France – 98/79 Website contact@bio-rad.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Cepheid FDA Sweden – 98/79 Website EUDAMED record Report an error
Core Technology FDA EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Daan Gene EU representative : MDSS GmbH (Germany) China – 98/79 EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com EUDAMED record Report an error
Hain Lifescience Germany D IVDR 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
Roche FDA Germany D IVDR 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
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
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) 9

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
Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories United States VITROS P030026 (2023)
Biokit, S.A. Present in Europe in other categories Spain – registered
Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti Türkiye – 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 – P130015 (2025)
Siemens Corp. United States – P110041 (2025)
Tosoh Bioscience, Inc. United States – registered

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