Skip to content
Emdyca

Infectious diseasesOther virology tests (infect. immunology/NAT)Other virology antigen/antibody detection

Respiratory syncytial virus (rsv)

EMDN code W0105040605

34 manufacturers, 57 models including 53 on the market, 11 countries

Export to CSV
Manufacturers registered in Europe (EUDAMED) 34
  • 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
Gold Standard Diagnostics FDA Germany
1 other
 – 98/79 info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
1 other
 – 98/79 Website info@testlinecd.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
Euroimmun FDA Germany – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China – 98/79 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
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Vircell Spain – 98/79 EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@anbio.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain) China – 98/79 sales@dbluemedical.com EUDAMED record Report an error
Arcdia Finland – 98/79 Website office@arcdia.com 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
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China – 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
Hangzhou Alltest Biotech FDA EU representative : VidaQuick Biotech S.L. (Spain) China – 98/79 info@alltests.com.cn 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
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 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
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website 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
Pluslife EU representative : Medunion S.L. (Spain) China – 98/79 Website ra@pluslife.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
Sansure FDA EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China B IVDR Website 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) No model still on the market China – 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
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) 26

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
Alere Scarborough, Inc. United States BinaxNOW RSV BinaxNOW Nasopharyngeal Swab Accessory Kit BinaxNOW RSV Control Swab Kit registered
Quidel Corp. United States QuickVue Sofia K162911 (2017)
AMERICAN BIO MEDICA CORPORATION – RDS Easy Lab Pro RSV registered
BTNX Inc – Rapid Response registered
Becton, Dickinson & CO Present in Europe in other categories United States 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
Response Biomedical Corp. Present in Europe in other categories Canada RAMP® RSV TEST KIT; 25 TESTS RAMP® RSV Control Swabs K091235 (2009)
DIESSE DIAGNOSTICA SENESE SPA Present in Europe in other categories United States CHORUS RESPIRATORY SYNCYTIAL VIRUS IgG registered
Hangzhou Clongene Biotech Co., Ltd. Present in Europe in other categories China CLUNGENE K253318 (2026)
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
Sekisui Diagnostics, LLC Present in Europe in other categories United States OSOM RSV Test registered
Abbott Laboratories Present in Europe in other categories United States – K882277 (1988)
BioSquare Inc. South Korea – registered
CBR Enterprise Limited Hong Kong SAR 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

Didn't find it?

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

Related categories