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Emdyca

ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Epstein barr virus

EMDN code W01050404

61 manufacturers, 220 models including 217 on the market, 15 countries

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Manufacturers registered in Europe (EUDAMED) 61
  • 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
TestLine Clinical Diagnostics s.r.o Czechia
18 others
 – 98/79 Website info@testlinecd.com EUDAMED record Report an error
Euroimmun FDA Germany
10 others
 – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Vidia Czechia
9 others
 – 98/79 Website EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland) United States
8 others
 – 98/79 Website EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China
7 others
 – 98/79 Website EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
4 others
 – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Vircell Spain
3 others
 B IVDR, 98/79 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
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia
1 other
 – 98/79 Website EUDAMED record Report an error
Viramed FDA Germany
1 other
 B IVDR Website EUDAMED record Report an error
Mikrogen Germany – 98/79 EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website info@szyhlo.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
Autobio Diagnostics FDA EU representative : QbD RepS BV (Belgium) China – 98/79 info@autobio-diagnostics.com EUDAMED record Report an error
bioMérieux FDA France B, C IVDR EUDAMED record Report an error
DiaSorin FDA Italy B IVDR Website 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
Technogenetics FDA Italy B IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Vitrosens Türkiye C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
altona Diagnostics FDA Germany C IVDR, 98/79 info@altona-diagnostics.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye – 98/79 Website EUDAMED record Report an error
Daan Gene EU representative : MDSS GmbH (Germany) China – 98/79 EUDAMED record Report an error
Geneproof Czechia C IVDR, 98/79 Website support@geneproof.com EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China C IVDR, 98/79 Website info@sansure.com.cn 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
Abbott FDA EU representative : Abbott GmbH (Germany) United States C IVDR 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
Diesse FDA Italy C IVDR Website 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
Progenie molecular S.L.U Spain – 98/79 EUDAMED record Report an error
Qiagen FDA Germany – 98/79 Website info@qiagen.com EUDAMED record Report an error
Seramun Germany – 98/79 info@seramun.com EUDAMED record Report an error
Targetingone EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Ab Analitica Italy – 98/79 customersupport@abanalitica.it 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
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) United States – 98/79 Website info.dk@agilent.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye – 98/79 Website info@anatoliagenetik.com EUDAMED record Report an error
Anchor Diagnostics Germany – 98/79 info@anchor-diagnostics.com EUDAMED record Report an error
Certest Spain C IVDR Website quality@certest.es EUDAMED record Report an error
Clonit Italy C IVDR Website info@clonit.it EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Demeditec FDA Germany – 98/79 Website info@demeditec.de EUDAMED record Report an error
Diagenode FDA Belgium C IVDR info@diagenode.com EUDAMED record Report an error
Dialab Austria – 98/79 Website office@dialab.at EUDAMED record Report an error
Diapro Italy – 98/79 Website info@diapro.it EUDAMED record Report an error
Ecolidx Czechia – 98/79 Website EUDAMED record Report an error
ElitechGroup FDA Italy C IVDR Website EUDAMED record Report an error
Genekam Germany – 98/79 Website office@genekam.de EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
Iontek Türkiye – 98/79 Website EUDAMED record Report an error
Norgen Biotek EU representative : Emergo Europe B.V. (Netherlands) Canada B IVDR Website regulatory@norgenbiotek.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye C IVDR Website info@visionbiotechnology.com 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

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) 13

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
Bio-Rad Present in Europe in other categories United States BioPlex 2200 Bio-Rad Laboratories Bio-Rad K062211 (2006)
CLARK LABORATORIES, INC. United States Trinity Biotech Bio-Rad Platelia Platelia K980596 (1998)
Quest Intl., Inc. United States ReQuest SeraQuest K091260 (2009)
Diamedix Corp. United States Diamedix K981812 (1999)
ARLINGTON SCIENTIFIC, INC. United States ASI EB VCA IgG EIA Test ASI EBNA IgG EIA Test registered
SCIMEDX CORPORATION – EBV EA 10 Well; 10 pk EBV-EA IgG 120 Test Kit registered
BIOCHECK, INC. United States – registered
Biokit, S.A. Present in Europe in other categories Spain – K233606 (2024)
Calbiotech, Inc. United States – registered
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Immuno Concepts, Inc. Present in Europe in other categories United States – K912488 (1991)
Roche Diagnostics Corp. Present in Europe in other categories United States – K260221 (2026)
Zeus Scientific, Inc. Present in Europe in other categories United States – K983801 (1998)

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