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Emdyca

IVD instrumentsNucleic acid testing instrumentsNucleic acid testing instruments except micro-arrays

Nucleic acid testing integrated extraction /amplification /detection systems

EMDN code W02050116

112 manufacturers, 288 models including 285 on the market, 18 countries

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Manufacturers registered in Europe (EUDAMED) 112
  • 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
Vitrosens Türkiye
17 others
 A IVDR Website info@vitrosens.com EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany) China
14 others
 A IVDR Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Hybribio EU representative : Kingsmead Service B.V. (Netherlands) China
3 others
 A IVDR EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
2 others
 A IVDR Website sales@bioneer.com EUDAMED record Report an error
MagBio Genomics FDA EU representative : CEpartner4U (Netherlands) United States
2 others
 A IVDR Website info@magbiogenomics.com EUDAMED record Report an error
PentaBase Denmark
2 others
 A IVDR Website info@pentabase.com EUDAMED record Report an error
Qiagen FDA Germany
2 others
 A IVDR Website info@qiagen.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China
2 others
 A IVDR Website info@sansure.com.cn EUDAMED record Report an error
Taiwan Advanced Nanotech FDA EU representative : mdi Europa GmbH (Germany) Taiwan
2 others
 A IVDR Website EUDAMED record Report an error
Zhuhai Shineway Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
2 others
 A IVDR Website EUDAMED record Report an error
Biocomma EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 A IVDR Website sales@biocomma.cn EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) China
1 other
 A IVDR PMS@zy-ivd.com EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Linear FDA Spain A IVDR Website info@linear.es EUDAMED record Report an error
Optolane FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR info@optolane.com EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
DNA-Technology, Research & Production EU representative : Obelis s.a. (Belgium) Russia A IVDR Website EUDAMED record Report an error
Guangdong RunPon Bioscience EU representative : Share info GmbH (Germany) China A IVDR Service_RP@fapon.com EUDAMED record Report an error
Life Technologies Holdings Pte EU representative : Life Technologies Europe B.V. (Netherlands) Singapore A IVDR EUDAMED record Report an error
Molarray EU representative : Caretechion GmbH (Germany) China A IVDR EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Vazyme EU representative : Caretechion GmbH (Germany) and 1 other China A IVDR EUDAMED record Report an error
Genesystem FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website ra@genesystem.co.kr EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) United States A IVDR ratransfusionmedicine@abbott.com EUDAMED record Report an error
Aperbio Technologies (Suzhou) EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France) United States A IVDR EUDAMED record Report an error
Coyotebio EU representative : QbD RepS BV (Belgium) China A IVDR sales@coyotebio.com EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
RevoSketch EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR Website EUDAMED record Report an error
Rocgene FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR sale@rocgene.com EUDAMED record Report an error
Wallac Finland A IVDR Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Wizbiosolution EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR EUDAMED record Report an error
Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) Singapore A IVDR Website EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye A IVDR Website info@anatoliagenetik.com EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium) China A IVDR Website EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany) Taiwan A IVDR service@credodxbiomed.com EUDAMED record Report an error
Diagnostics For Real World Europe FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United Kingdom (ex Northern Ireland) A IVDR Website qa@drw-ltd.com EUDAMED record Report an error
GenMark Diagnostics FDA EU representative : Roche Diagnostics GmbH (Germany) United States A IVDR regulatory.rmd_international@roche.com EUDAMED record Report an error
Human Germany A IVDR Website EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China A IVDR EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website info@khmedical.co.kr EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States A IVDR Website EUDAMED record Report an error
Pluslife EU representative : PureCE B.V. (Netherlands) and 1 other China A IVDR Website ra@pluslife.com EUDAMED record Report an error
Precision System Science FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR service@pss.co.jp EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website sales@szzijian.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR sales@singuway.com EUDAMED record Report an error
Xi An Tianlong Science Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China A IVDR info@zsandx.com EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium) China A IVDR Website EUDAMED record Report an error
Ab Analitica Italy A IVDR customersupport@abanalitica.it EUDAMED record Report an error
AD Nucleis France A IVDR Website EUDAMED record Report an error
Adaltis Italy – 98/79 Website info@adaltis.net EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore A IVDR Website info.dk@agilent.com EUDAMED record Report an error
Anhui Wanyi Science Technology EU representative : Eunitor GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Appolon Bioteck France A IVDR Website contact@appolonbioteck.com EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China A IVDR EUDAMED record Report an error
Bgi Denmark A IVDR Website EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Biocartis FDA Belgium A IVDR Website regulatory@biocartis.com EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Bioeksen Türkiye A IVDR Website info@bioeksen.com.tr EUDAMED record Report an error
Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Website info@bioteke.cn EUDAMED record Report an error
Brightbiomed EU representative : MedPath GmbH (Germany) China A IVDR info@brightbiomed.com EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden) United States A IVDR Website EUDAMED record Report an error
Chengdu One-Chip Biotechnology EU representative : Share info GmbH (Germany) China A IVDR EUDAMED record Report an error
Chongqing ME Instruments Technology EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Delbio EU representative : Emergo Europe B.V. (Netherlands) Taiwan A IVDR Website EUDAMED record Report an error
Dermagnostix Germany – 98/79 Website info@dermagnostix.com EUDAMED record Report an error
Ecolidx Czechia A IVDR Website EUDAMED record Report an error
Element Biosciences EU representative : QbD RepS BV (Belgium) United States A IVDR support@elembio.com EUDAMED record Report an error
ElitechGroup FDA Italy A IVDR Website EUDAMED record Report an error
Geneplus EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Geneproof Czechia A IVDR Website support@geneproof.com EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH Germany A IVDR Website info@gfeblut.de EUDAMED record Report an error
Grifols FDA EU representative : Diagnostic Grifols, S.A. (Spain) United States A IVDR Website RegulatoryAffairs_DxBU@grifols.com EUDAMED record Report an error
Hangzhou Bigfish Bio-tech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hangzhou Bio-gener Technology EU representative : MedPath GmbH (Germany) China A IVDR info@bio-gener.com EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hanwooltpc FDA EU representative : Javitech Consulting GmbH (Germany) South Korea A IVDR 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
Hyris Italy A IVDR Website support@hyris.net EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea A IVDR EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR support@igenesisbio.com EUDAMED record Report an error
Infitek FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Intron EU representative : Obelis s.a. (Belgium) South Korea A IVDR EUDAMED record Report an error
Katsura EU representative : Kingsmead Service B.V. (Netherlands) Taiwan A IVDR Website EUDAMED record Report an error
Lifereal EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Longgene EU representative : MedPath GmbH (Germany) China A IVDR info@longgene.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States A IVDR Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Masmec FDA Italy A IVDR Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) United States A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Personalgenome FDA EU representative : Emergo Europe B.V. (Netherlands) United States C IVDR Website EUDAMED record Report an error
Quantidx Hong Kong EU representative : MedPath GmbH (Germany) Hong Kong SAR China A IVDR EUDAMED record Report an error
R-Biopharm FDA Germany A IVDR Website EUDAMED record Report an error
Rgbio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website info@seegene.com EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : Lotus NL B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Shenzhen Uni-medica Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website marketing@uni-medica.com EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) Japan A IVDR csc@tosoh.co.jp EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye A IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium) China A IVDR Website sales@wondfo.com.cn EUDAMED record Report an error
Zinexts EU representative : Obelis s.a. (Belgium) Taiwan A IVDR Website EUDAMED record Report an error
Mobidiag No model still on the market Finland A IVDR Website sales.mob@hologic.com EUDAMED record Report an error
Uniogen No model still on the market Finland A IVDR info@uniogen.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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