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Infectious diseasesInfectious immunology - rapid tests & point of careOther virology RT & POC

Virology - RT & POC - other

EMDN code W0105099099

109 manufacturers, 1,231 models including 1,211 on the market, 16 countries

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Manufacturers registered in Europe (EUDAMED) 109
  • 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
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Germany, South Korea
112 others
– 98/79 Website EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
71 others
B, C IVDR, 98/79 info@alltests.com.cn EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
61 others
– 98/79 info@acrobiotech.com EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China
37 others
– 98/79 info@vivachek.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) United States
35 others
– 98/79 info@acesolab.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China
32 others
– 98/79 Website info@kylinew.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
31 others
– 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain) Canada
28 others
– 98/79 ra02@citestdiagnostics.com EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain) China
27 others
– 98/79 info@actest.com.cn EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain) China
26 others
– 98/79 EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
25 others
– 98/79 Website EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
23 others
– 98/79 info@genesignbio.com EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain) China
21 others
– 98/79 info@bitrumed.com.cn EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other China
19 others
– 98/79 Website marketing@clongene.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
19 others
B, C IVDR, 98/79 EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
17 others
B IVDR, 98/79 Website contact@diareagent.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
Shanghai BioGerm Medical Technology EU representative : Medunion S.L. (Spain) China
16 others
– 98/79 EUDAMED record Report an error
Biotical Spain
15 others
– 98/79 Website EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
15 others
– 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Safecare FDA EU representative : UnicareQ GmbH (Germany) and 1 other China
14 others
– 98/79 EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other China
12 others
– 98/79 office@guoke-medical.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
11 others
– 98/79 marketing@hongweitest.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
18 others
– 98/79 EUDAMED record Report an error
Beijing Kewei Clinical Diagnostic Reagent EU representative : Lotus NL B.V. (Netherlands) China
10 others
– 98/79 Website EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
10 others
– 98/79 info@sup-bio.com EUDAMED record Report an error
Certest Spain
9 others
B IVDR Website quality@certest.es EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany) China
8 others
– 98/79 sales@accubiotech.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
8 others
– 98/79 Website sales@szzijian.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China
7 others
– 98/79 EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China
7 others
– 98/79 Website EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China
6 others
– 98/79 info@vivachek.com EUDAMED record Report an error
Cesna Türkiye
5 others
B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Farmasino EU representative : Humiss International B.V. (Netherlands) China
5 others
– 98/79 EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
5 others
B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) China
4 others
– 98/79 EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
4 others
– 98/79 info@biotests.com.cn EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other China
4 others
B IVDR, 98/79 office@lyher.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other United States
4 others
– 98/79 quality@healgen.com EUDAMED record Report an error
Jiangsu Medomics Medical Technology FDA EU representative : Mega Eurostar Sp. z o.o. (Poland) and 2 others China
4 others
C IVDR, 98/79 Website info@medomics-dx.com EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
4 others
– 98/79 info@huiantech.com EUDAMED record Report an error
Zhejiang Wantaifu Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
4 others
– 98/79 Website EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other China
3 others
B, C IVDR, 98/79 sales@dbluemedical.com EUDAMED record Report an error
Salofa FDA Finland
3 others
– 98/79 Website info@salofa.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
2 others
– 98/79 Website EUDAMED record Report an error
Core Technology FDA EU representative : Medunion S.L. (Spain) and 1 other China
2 others
– 98/79 EUDAMED record Report an error
nal von minden Germany
2 others
– 98/79 Website info@nal-vonminden.com EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : Medunion S.L. (Spain) China
2 others
– 98/79 EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany) China
1 other
– 98/79 EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
1 other
– 98/79 info@konsung.com EUDAMED record Report an error
Operon FDA Spain
1 other
B IVDR, 98/79 Website infoeudamed@operon.es EUDAMED record Report an error
Tauns EU representative : Emergo Europe B.V. (Netherlands) Japan
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
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands) China – 98/79 EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Biomaxima Poland B IVDR Website info@biomaxima.com EUDAMED record Report an error
Sejoy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website EUDAMED record Report an error
Singclean EU representative : Obelis s.a. (Belgium) and 1 other China C IVDR, 98/79 Website 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
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Bioteke FDA EU representative : Medunion S.L. (Spain) China C IVDR, 98/79 Website info@bioteke.cn 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
Innovacon EU representative : MDSS GmbH (Germany) United States – 98/79 EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China B IVDR, 98/79 Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) China C IVDR, 98/79 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
Reagena Finland B IVDR, 98/79 Website info@reagena.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
Wesailbio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Artronlab FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other Canada – 98/79 Website info@artronlab.com 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
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium) China – 98/79 Website info@ksbbiotech.com EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Abcerion Diagnostics Germany – 98/79 Website info@abcerion-diagnostics.de 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
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany) China – 98/79 EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany) China – 98/79 EUDAMED record Report an error
R-Biopharm FDA Germany – 98/79 Website EUDAMED record Report an error
Vircell Spain B IVDR EUDAMED record Report an error
Vitrosens Türkiye B IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Wizbiotech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) China
2 others
– 98/79 Website info@sansure.com.cn 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
Aidian FDA Finland – 98/79 Website eudamed@aidian.eu EUDAMED record Report an error
Biodetect EU representative : Lotus NL B.V. (Netherlands) China – 98/79 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
Bioinova Czechia – 98/79 Website info@bioinova.cz EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France) Switzerland – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
CorDx FDA EU representative : Luxus Lebenswelt GmbH (Germany) United States – 98/79 EUDAMED record Report an error
Dyonmed Greece – 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
Equinox Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website sales@runbio-bio.com EUDAMED record Report an error
Erasinovasyon Türkiye C IVDR Website EUDAMED record Report an error
Fanttest EU representative : Cares Testtech GmbH (Germany) China – 98/79 info@fanttest.com EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Hangzhou DIAN Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Heyer Medical Germany C IVDR Website EUDAMED record Report an error
Innovita EU representative : SUNGO Europe B.V. (Netherlands) China C IVDR Website info@innovita.com.cn EUDAMED record Report an error
New Gene (Hangzhou) Bioengineering EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 Website marketing@new-gene.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
Pantest Portugal – 98/79 Website EUDAMED record Report an error
Qingdao Huaren Medical Product EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Reagen EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website info@reagenus.com EUDAMED record Report an error
Targetingone EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) 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
Arcdia No model still on the market Finland – 98/79 Website office@arcdia.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.

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