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ReagentsInfectious diseasesInfectious immunology - rapid tests & point of care

Other virology RT & POC

EMDN code W01050990

133 manufacturers, 751 models including 740 on the market, 21 countries

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Manufacturers registered in Europe (EUDAMED) 133
  • 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
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
40 others
B, C IVDR, 98/79 info@alltests.com.cn EUDAMED record Report an error
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other South Korea, United States
25 others
– 98/79 Website EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
20 others
– 98/79 info@acrobiotech.com EUDAMED record Report an error
Vitrosens Türkiye
19 others
B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States
18 others
– 98/79 quality@healgen.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
17 others
– 98/79 EUDAMED record Report an error
Safecare FDA EU representative : Medunion S.L. (Spain) and 3 others China
16 others
– 98/79 EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
13 others
C IVDR, 98/79 EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş Türkiye
13 others
– 98/79 Website info@turklab.com.tr EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
12 others
– 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) China
11 others
B, C IVDR, 98/79 office@lyher.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) United States
10 others
– 98/79 info@acesolab.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China
10 others
– 98/79 EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China
10 others
– 98/79 Website info@kylinew.com EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain) China
8 others
– 98/79 info@actest.com.cn EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands) China
8 others
– 98/79 EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain) China
8 others
– 98/79 info@bitrumed.com.cn EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain) China
8 others
– 98/79 EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) China
7 others
– 98/79 EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China
6 others
– 98/79 info@vivachek.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
6 others
B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
5 others
– 98/79 Website EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
5 others
– 98/79 Website sales@szzijian.com EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China
5 others
– 98/79 info@vivachek.com EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany) China
4 others
– 98/79 EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China
4 others
B, C IVDR, 98/79 Website EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany) China
3 others
– 98/79 sales@accubiotech.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) China
3 others
– 98/79 sales@dbluemedical.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
3 others
B, C IVDR, 98/79 Website contact@diareagent.com 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
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
3 others
– 98/79 info@biotests.com.cn EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
3 others
– 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China
2 others
– 98/79 Website EUDAMED record Report an error
Biomaxima Poland
2 others
B IVDR Website info@biomaxima.com EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China
2 others
– 98/79 Website EUDAMED record Report an error
nal von minden Germany
2 others
– 98/79 Website info@nal-vonminden.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
3 others
– 98/79 Website EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye
1 other
– 98/79 Website EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China
1 other
– 98/79 EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other China
1 other
– 98/79 Website marketing@clongene.com EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany) China
1 other
– 98/79 EUDAMED record Report an error
Tisenc EU representative : QbD RepS BV (Belgium) China
1 other
– 98/79 Website EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other China – 98/79 ra.rep@aichek.com EUDAMED record Report an error
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France) Switzerland – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain) Canada – 98/79 ra02@citestdiagnostics.com 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
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website info@labnovation.com EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany) Germany, Singapore – 98/79 Website EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany) China – 98/79 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
Zhejiang Wantaifu Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website EUDAMED record Report an error
Actim FDA Finland – 98/79 Website support@actimtest.com EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China – 98/79 Website 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
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium) China – 98/79 Website info@ksbbiotech.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
Tauns EU representative : Emergo Europe B.V. (Netherlands) Japan – 98/79 Website EUDAMED record Report an error
Arkray FDA EU representative : Arazy Group GmbH (Germany) India B, C IVDR Website 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
Calth EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR, 98/79 Website info@thecalth.com EUDAMED record Report an error
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China B IVDR, 98/79 Website EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China C IVDR, 98/79 Website info@gensurebio.com EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea – 98/79 EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Ningbo BESTest Bio-technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Vircell Spain B IVDR, 98/79 EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Beijing North Institute of Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@eugenebio.com EUDAMED record Report an error
Certest Spain B IVDR Website quality@certest.es EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany) United States B 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
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China – 98/79 info@genesignbio.com EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Caretechion GmbH (Germany) China – 98/79 Website marketing@era-bio.com EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China – 98/79 EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 Website sales@limingbio.com EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Operon FDA Spain B IVDR Website infoeudamed@operon.es 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
Shenzhen Huian Biosci Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 info@huiantech.com EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website info@tibchina.com EUDAMED record Report an error
Wizbiotech EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Zetmedikal Türkiye – 98/79 Website info@zetmedikal.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
Aaz Productions Le Materiel Biomedical France – 98/79 EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany) China – 98/79 EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@acmexbio.com EUDAMED record Report an error
Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@anbio.com EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany) Canada – 98/79 Website info@artronlab.com EUDAMED record Report an error
Azubio Diagnostics EU representative : CMC Medical Devices & Drugs SL (Spain) China C IVDR EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other China – 98/79 EUDAMED record Report an error
Biokit FDA Spain B IVDR EUDAMED record Report an error
Biopanda Northern Ireland – 98/79 Website info@biopanda.co.uk EUDAMED record Report an error
Cesna Türkiye B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain) China – 98/79 Website EUDAMED record Report an error
Dynamiker EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website marketing@dynamiker.com EUDAMED record Report an error
Dyonmed Greece – 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com EUDAMED record Report an error
Farmasino EU representative : Humiss International B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Giesse Diagnostics Italy – 98/79 Website info@giessediagnostics.com EUDAMED record Report an error
Gold Probe Diagnostic Biotechnology Mf EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website export@goldsite.com.cn 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
Hangzhou Higene Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Hecin EU representative : Share info GmbH (Germany) China B IVDR EUDAMED record Report an error
Hotgen FDA EU representative : MedNet EC-REP GmbH (Germany) China B IVDR service@hotgen.com.cn EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@konsung.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
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (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
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China – 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
Sanymed Italy – 98/79 Website info@sanymed.it EUDAMED record Report an error
Screen Italia Italy – 98/79 Website info@screenitalia.it EUDAMED record Report an error
Sekisui Diagnostics FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Shanghai Zymetas Medtech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany) Egypt – 98/79 Website EUDAMED record Report an error
Whpm FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 customerservice@whpm.com.cn 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
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) 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
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
Human No model still on the market Germany – 98/79 Website EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) 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.

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