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Emdyca

ReagentsInfectious diseasesOther virology tests (infect. immunology/NAT)

Other virology antigen/antibody detection

EMDN code W01050406

125 manufacturers, 914 models including 886 on the market, 18 countries

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Manufacturers registered in Europe (EUDAMED) 125
  • 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
Euroimmun FDA Germany
76 others
 B IVDR, 98/79 Website info@euroimmun.de EUDAMED record Report an error
Gold Standard Diagnostics FDA Germany
49 others
 – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Vitrosens Türkiye
44 others
 B, 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
35 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
31 others
 C IVDR, 98/79 Website info@testlinecd.com EUDAMED record Report an error
Vircell Spain
30 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia
28 others
 – 98/79 Website EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
26 others
 – 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
24 others
 – 98/79 EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States
23 others
 – 98/79 quality@healgen.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
21 others
 – 98/79 info@acrobiotech.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China
21 others
 – 98/79 Website EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea
11 others
 B IVDR, 98/79 Website marketing@boditech.co.kr EUDAMED record Report an error
Arcdia Finland
8 others
 – 98/79 Website office@arcdia.com EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
8 others
 – 98/79 info@jgbiotech.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
7 others
 B IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş Türkiye
7 others
 – 98/79 Website info@turklab.com.tr EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China
5 others
 – 98/79 EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
5 others
 – 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
5 others
 – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China
5 others
 – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
4 others
 – 98/79 info@biotests.com.cn EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other China
3 others
 – 98/79 office@guoke-medical.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
3 others
 – 98/79 Website EUDAMED record Report an error
Medotexbio EU representative : HUMISS TRADING S. L. (Spain) and 1 other China
3 others
 – 98/79 Website EUDAMED record Report an error
Vidia Czechia
3 others
 – 98/79 Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
3 others
 C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China
2 others
 – 98/79 info@cybereagen.com EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) Italy, United States
2 others
 C IVDR, 98/79 Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Diesse FDA Italy
2 others
 B, C IVDR Website EUDAMED record Report an error
Inbios FDA EU representative : AR Experts B.V. (Netherlands) United States
2 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
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China
2 others
 – 98/79 info@vivachek.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain) China
1 other
 – 98/79 sales@dbluemedical.com EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye
1 other
 – 98/79 Website EUDAMED record Report an error
Mikrogen Germany
1 other
 – 98/79 EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
1 other
 – 98/79 Website eudamed@nanoentek.com EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland)
1 other
 – 98/79 Website EUDAMED record Report an error
R-Biopharm FDA Germany
1 other
 B IVDR, 98/79 Website EUDAMED record Report an error
Seramun Germany
1 other
 – 98/79 info@seramun.com EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
1 other
 B IVDR Website EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 – 98/79 EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
bioMérieux FDA France B, C IVDR EUDAMED record Report an error
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China – 98/79 Website marketing@dynamiker.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
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Ningbo BESTest Bio-technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B, C IVDR, 98/79 EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 info@anbio.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
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website info@gensurebio.com EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Reagena Finland – 98/79 Website info@reagena.com EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Diapro Italy – 98/79 Website info@diapro.it 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
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti Türkiye – 98/79 Website info@koroglugroup.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Hong Kong SAR China – 98/79 Website info@phasesci.com EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website info@realytech.com EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 info@huiantech.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
Toda Pharma France – 98/79 Website qualite@todapharma.com EUDAMED record Report an error
Vellap Germany – 98/79 info@vellap.de EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium) China – 98/79 EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany) China – 98/79 sales@accubiotech.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Autobio Diagnostics FDA EU representative : QbD RepS BV (Belgium) China C IVDR info@autobio-diagnostics.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Campmedica Romania B IVDR, 98/79 Website EUDAMED record Report an error
Clonit Italy – 98/79 Website info@clonit.it EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com 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
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea – 98/79 EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 marketing@hongweitest.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Mpbio FDA Germany – 98/79 Website EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Technogenetics FDA Italy C IVDR Website QA@TECHNOGENETICS.IT 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
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany) China – 98/79 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 Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) 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
Beijing Zhongjian Antai Diagnostic Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China B IVDR EUDAMED record Report an error
Bio-Rad FDA France C IVDR Website contact@bio-rad.com 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
Biopanda Northern Ireland – 98/79 Website info@biopanda.co.uk EUDAMED record Report an error
Biosynex France – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Certest Spain B IVDR Website quality@certest.es EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany) United States C IVDR Website info@ctkbiotech.com EUDAMED record Report an error
Dutch Diagnostics Netherlands – 98/79 Website info@dutch-diagnostics.com EUDAMED record Report an error
GenDx FDA EU representative : MedEnvoy Global BV (Netherlands) United States – 98/79 Website orders@genbio.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Genesignbio EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 info@genesignbio.com EUDAMED record Report an error
Hangzhou Testsea 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
Immundiagnostik FDA Germany – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Kangmei Tianhong Biotech (Beijing) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website info@kindmay.com EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France) United States B IVDR EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 Website EUDAMED record Report an error
Monlab Spain – 98/79 Website EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website sales@syngenebio.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China – 98/79 Website info@kylinew.com EUDAMED record Report an error
Pluslife EU representative : Medunion S.L. (Spain) China – 98/79 Website ra@pluslife.com EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 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
Shenzhen Superbio Technology FDA EU representative : QbD RepS BV (Belgium) China – 98/79 info@sup-bio.com 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
Todylaboratories Romania A IVDR Website contact@todylaboratories.com EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands) 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
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other No model still on the market China
6 others
 – 98/79 EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market China
2 others
 – 98/79 EUDAMED record Report an error
Biotime EU representative : Medunion S.L. (Spain) No model still on the market China – 98/79 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.

Other manufacturers known in the United States (FDA) 30

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
Princeton BioMeditech Corp. Present in Europe in other categories United States BioSign Flu A+B card Status Flu A+B card Status Flu A+B Validation Kit Status Flu A & B Status Flu A+B Nasal Wash/Aspirate Kit registered
Quidel Corp. United States QuickVue Sofia K162911 (2017)
Alere Scarborough, Inc. United States BinaxNOW RSV BinaxNOW Nasopharyngeal Swab Accessory Kit BinaxNOW RSV Control Swab Kit registered
Becton, Dickinson & CO Present in Europe in other categories United States BD Veritor™ System Laboratory Combo Pack BD Veritor™ Plus CLIA-Waived Combo Pack BD Veritor™ System For Rapid Detection of RSV - CLIA waived kit BD Veritor™ System For Rapid Detection of RSV - Laboratory kit K133140 (2013)
MCKESSON MEDICAL-SURGICAL INC. – McKesson registered
AMERICAN BIO MEDICA CORPORATION – RDS Easy Lab Pro RSV registered
BTNX Inc – Rapid Response registered
Polymedco, Inc. United States Poly stat registered
Response Biomedical Corp. Present in Europe in other categories Canada RAMP® RSV TEST KIT; 25 TESTS RAMP® RSV Control Swabs K091235 (2009)
Sekisui Diagnostics, LLC Present in Europe in other categories United States OSOM Ultra Flu A&B Controls 5 Test OSOM RSV Test K123182 (2012)
Zhengzhou Shiyi Biotech Co., Ltd. – – registered
HENRY SCHEIN, INC. Present in Europe in other categories United States Henry Schein registered
Hangzhou Clongene Biotech Co., Ltd. Present in Europe in other categories China CLUNGENE K253318 (2026)
LONGEVITI NEURO SOLUTIONS LLC – Longeviti Convenience Kit 5.0 registered
Meridian Bioscience, Inc. Present in Europe in other categories United States TRU RSV K041445 (2004)
NANO-DITECH CORPORATION United States Nano-Check RSV Test K240280 (2024)
Rodimedi & Associates, Inc. – Red Tunica registered
BioSquare Inc. South Korea – registered
CBR Enterprise Limited Hong Kong SAR China – registered
Hangzhou Rollmed Co.,Ltd. China – registered
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd China – registered
NOVEM MEDICAL S. DE R.L. DE C.V. Mexico – registered
Panion & BF Biotech, Inc. Taiwan – registered
Planet Innovation Products, Inc. United States – registered
QuidelOrtho Corporation United States – registered
STS Corporation United States – registered
Sa Scientific, Inc. United States – K022845 (2003)
Sanicure BV Netherlands – registered
Scantibodies Laboratory Inc. United States – registered
Via systems Manufacturas Mexico – registered

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