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Emdyca

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

Viral antigen/antibody detection - other

EMDN code W0105040699

50 manufacturers, 219 models including 197 on the market, 9 countries

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Manufacturers registered in Europe (EUDAMED) 50
  • 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
24 others
C IVDR, 98/79 Website info@euroimmun.de EUDAMED record Report an error
Biodetect EU representative : SUNGO Europe B.V. (Netherlands) China
10 others
– 98/79 Website EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain) China
7 others
A IVDR, 98/79 EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
6 others
B IVDR, 98/79 info@alltests.com.cn EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
4 others
– 98/79 EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China
4 others
– 98/79 info@vivachek.com 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
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
2 others
– 98/79 marketing@hongweitest.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) China
2 others
– 98/79 EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
– 98/79 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
Vitrosens Türkiye
1 other
B IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany) and 1 other China – 98/79 EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website eudamed@nanoentek.com EUDAMED record Report an error
Tongzhoubio FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR, 98/79 EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 Website sales@szzijian.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
Core Technology FDA EU representative : Medunion S.L. (Spain) and 1 other China – 98/79 EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China – 98/79 info@biotests.com.cn EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@cybereagen.com 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
Mikrogen Germany – 98/79 EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website 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
Anbio EU representative : Lotus NL B.V. (Netherlands) 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
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain) China C IVDR Website info@diagreat.com EUDAMED record Report an error
Dutch Diagnostics Netherlands – 98/79 Website info@dutch-diagnostics.com 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
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Hangzhou Testsea Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 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
Hecin EU representative : Share info GmbH (Germany) China B IVDR EUDAMED record Report an error
Idilbiotech Türkiye – 98/79 Website EUDAMED record Report an error
Inbios FDA EU representative : AR Experts B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 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 Dba Quidel EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany) South Korea – 98/79 Website info@precision-bio.com EUDAMED record Report an error
Realmindbio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 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 Superbio Technology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@sup-bio.com EUDAMED record Report an error
Vellap Germany – 98/79 info@vellap.de EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) and 1 other No model still on the market China
9 others
– 98/79 qa@egens-bio.cn EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) and 1 other No model still on the market China
3 others
– 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.

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