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Emdyca

ReagentsInfectious diseases

Bacteriology (infect. immunology/NAT)

EMDN code W010501

278 manufacturers, 2,753 models including 2,679 on the market, 32 countries

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ManufacturerCountryRegistered modelsClassContact
SSI Diagnostica Denmark
151 others
 – 98/79 Website info@ssidiagnostica.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
140 others
 B IVDR, 98/79 Website info@testlinecd.com EUDAMED record Report an error
Vitrosens Türkiye
109 others
 B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Euroimmun Germany
88 others
 B, C IVDR, 98/79 Website info@euroimmun.de EUDAMED record Report an error
Gold Standard Diagnostics Germany
80 others
 – 98/79 Website info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta) Canada
72 others
 – 98/79 Website support@pro-lab.com EUDAMED record Report an error
Vircell Spain
68 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Hangzhou Alltest Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
60 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
37 others
 B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Shanghai Zj Bio-Tech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
36 others
 – 98/79 Website EUDAMED record Report an error
Atlas Medical Germany
33 others
 – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Sansure EU representative : Obelis s.a. (Belgium) China
32 others
 C IVDR, 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Mikrogen Germany
29 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Orientgene EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
27 others
 – 98/79 EUDAMED record Report an error
Acro Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
26 others
 – 98/79 info@acrobiotech.com EUDAMED record Report an error
Hangzhou Laihe Biotech EU representative : Medunion S.L. (Spain) and 1 other China
26 others
 B, C IVDR, 98/79 office@lyher.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
25 others
 – 98/79 Website EUDAMED record Report an error
Healgen EU representative : CMC Medical Devices & Drugs SL (Spain) United States
25 others
 – 98/79 quality@healgen.com EUDAMED record Report an error
Anhui Deepblue Medical Technology EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other China
23 others
 – 98/79 sales@dbluemedical.com EUDAMED record Report an error
Chronolab Spain
23 others
 – 98/79 Website info@chronolab.com EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany) Egypt
23 others
 – 98/79 Website info@spectrum-diagnostics.com EUDAMED record Report an error
DiaSorin EU representative : DiaSorin Italia S.p.A. (Italy) Italy, United States
21 others
 A, B, C IVDR, 98/79 Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Idilbiotech Türkiye
21 others
 – 98/79 Website EUDAMED record Report an error
R-Biopharm Germany
21 others
 B, C IVDR, 98/79 Website EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
21 others
 – 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Sanymed Italy
20 others
 – 98/79 Website info@sanymed.it EUDAMED record Report an error
Fortress Diagnostics Northern Ireland
19 others
 – 98/79 Website info@fortressdiagnostics.com EUDAMED record Report an error
Viramed Germany
19 others
 B, C IVDR Website EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany) China
17 others
 – 98/79 EUDAMED record Report an error
Vidia Czechia
17 others
 – 98/79 Website EUDAMED record Report an error
Dialab Austria
16 others
 – 98/79 Website office@dialab.at EUDAMED record Report an error
gerbion Germany
16 others
 – 98/79 info@gerbion.com EUDAMED record Report an error
Seramun Germany
16 others
 B IVDR, 98/79 info@seramun.com EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China
15 others
 – 98/79 info@cybereagen.com EUDAMED record Report an error
Abbott EU representative : Abbott GmbH (Germany) and 2 others Germany, South Korea, United States
14 others
 C IVDR, 98/79 Website EUDAMED record Report an error
Orgentec Germany
14 others
 – 98/79 Website EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China
14 others
 B, C IVDR, 98/79 Website service@bioustar.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China
13 others
 – 98/79 EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye
12 others
 – 98/79 Website EUDAMED record Report an error
Diagnostics Belgium
12 others
 – 98/79 Website EUDAMED record Report an error
Diesse Italy
12 others
 B, C IVDR Website EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia
12 others
 – 98/79 Website EUDAMED record Report an error
Ecolidx Czechia
11 others
 – 98/79 Website EUDAMED record Report an error
Geneproof Czechia
11 others
 C IVDR, 98/79 Website support@geneproof.com EUDAMED record Report an error
Lorne Laboratories EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
11 others
 – 98/79 Website info@lornelabs.com EUDAMED record Report an error
LTA Italy
11 others
 – 98/79 Website office@ltaonline.it EUDAMED record Report an error
Bioperfectus EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
10 others
 – 98/79 EUDAMED record Report an error
Hain Lifescience Germany
10 others
 C IVDR, 98/79 EUDAMED record Report an error
Oxoid EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland)
10 others
 B, C IVDR, 98/79 Website EUDAMED record Report an error
Giesse Diagnostics Italy
9 others
 – 98/79 Website info@giessediagnostics.com EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
9 others
 – 98/79 info@jgbiotech.com EUDAMED record Report an error
Poly Diagnostics Luxembourg
9 others
 B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
8 others
 B IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China
8 others
 – 98/79 EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India
8 others
 – 98/79 Website EUDAMED record Report an error
Wondfo EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
8 others
 – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Labsystems Diagnostics Finland
7 others
 – 98/79 Website EUDAMED record Report an error
Molbio Diagnostics EU representative : QbD RepS BV (Belgium) India
7 others
 – 98/79 Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Monobind EU representative : AR Experts B.V. (Netherlands) United States
7 others
 – 98/79 Website info@monobind.com EUDAMED record Report an error
Remel Europe EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland)
7 others
 C IVDR, 98/79 Website EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany) Egypt
7 others
 – 98/79 Website EUDAMED record Report an error
Techlab EU representative : Emergo Europe B.V. (Netherlands) United States
7 others
 B IVDR, 98/79 Website EUDAMED record Report an error
Trinitybiotech EU representative : TrinityBiotech (Ireland) United States
7 others
 – 98/79 Website EUDAMED record Report an error
Xiamen Zeesan Biotech EU representative : Lotus NL B.V. (Netherlands) China
7 others
 – 98/79 info@zsandx.com EUDAMED record Report an error
ZeptoMetrix EU representative : Emergo Europe B.V. (Netherlands) United States
7 others
 B IVDR Website EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other China
6 others
 – 98/79 office@guoke-medical.com EUDAMED record Report an error
HangZhou Biotest  Biotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
6 others
 – 98/79 info@biotests.com.cn EUDAMED record Report an error
Immundiagnostik Germany
6 others
 – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Astra Biotech Germany
5 others
 – 98/79 Website info@astrabiotech.de EUDAMED record Report an error
Certest Spain
5 others
 B, C IVDR Website quality@certest.es EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China
5 others
 B IVDR, 98/79 Website EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany) China
5 others
 – 98/79 EUDAMED record Report an error
Suzhou TianLong Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other China
5 others
 – 98/79 EUDAMED record Report an error
Vitassay Spain
5 others
 – 98/79 Website info@vitassay.com EUDAMED record Report an error
VMRD EU representative : MediMark Europe Sarl. (France) United States
5 others
 – 98/79 Website EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China
4 others
 – 98/79 EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
4 others
 B, C IVDR Website info@diagreat.com EUDAMED record Report an error
Hightopbio EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
4 others
 – 98/79 Website EUDAMED record Report an error
Bio-Rad France
3 others
 B, C IVDR, 98/79 Website contact@bio-rad.com EUDAMED record Report an error
bioMérieux France
3 others
 B, C IVDR, 98/79 EUDAMED record Report an error
Clonit Italy
3 others
 – 98/79 Website info@clonit.it EUDAMED record Report an error
Genekam Germany
3 others
 – 98/79 Website office@genekam.de EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China
3 others
 – 98/79 Website EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
3 others
 B IVDR, 98/79 marketing@hongweitest.com EUDAMED record Report an error
Progenie molecular S.L.U Spain
3 others
 – 98/79 EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain) China
3 others
 – 98/79 Website info@realytech.com EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China
3 others
 – 98/79 info@vivachek.com EUDAMED record Report an error
Biosynex France
3 others
 C IVDR, 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Bioeksen Türkiye
2 others
 – 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
IBL International Germany
2 others
 – 98/79 Website EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Medunion S.L. (Spain) and 1 other China
2 others
 – 98/79 EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
2 others
 – 98/79 Website export@keyubio.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany) United States
2 others
 – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Arcdia Finland
1 other
 – 98/79 Website office@arcdia.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China
1 other
 – 98/79 EUDAMED record Report an error
Biocare Medical EU representative : Emergo Europe B.V. (Netherlands) United States
1 other
 – 98/79 Website EUDAMED record Report an error
Boditech EU representative : Obelis s.a. (Belgium) South Korea
1 other
 – 98/79 Website marketing@boditech.co.kr EUDAMED record Report an error
GenDx EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China, United States
1 other
 – 98/79 Website orders@genbio.com EUDAMED record Report an error
Getein EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 B, C IVDR, 98/79 EUDAMED record Report an error
Hangzhou Danwei Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 – 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 – 98/79 Website EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany) Egypt
1 other
 – 98/79 EUDAMED record Report an error
SD Biosensor EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
1 other
 B, C IVDR, 98/79 Website EUDAMED record Report an error
Vela Operations Singapore Pte EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore
1 other
 – 98/79 Website infoAPAC@veladx.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 – 98/79 EUDAMED record Report an error
Abacus Diagnostica Finland – 98/79 info@abacusdiagnostica.com EUDAMED record Report an error
Aesku Germany – 98/79 Website EUDAMED record Report an error
Capitalbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 EUDAMED record Report an error
Genmark Türkiye – 98/79 Website info@genmark.com.tr EUDAMED record Report an error
Hologic EU representative : Hologic BV (Belgium) United States C IVDR EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 Website sales@limingbio.com EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR, 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
Shenzhen Yhlo Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website info@szyhlo.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website sales@szzijian.com EUDAMED record Report an error
Spinreact Spain – 98/79 Website EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other China – 98/79 Website sales@tellgen.com EUDAMED record Report an error
TIB MOLBIOL Syntheselabor Germany – 98/79 Website EUDAMED record Report an error
Vellap Germany – 98/79 info@vellap.de EUDAMED record Report an error
altona Diagnostics Germany B IVDR, 98/79 info@altona-diagnostics.com EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other Australia – 98/79 Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Bgi Denmark – 98/79 Website EUDAMED record Report an error
Cellabs EU representative : WMDE B.V. (Netherlands) Australia – 98/79 Website enquiries@cellabs.com.au EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China – 98/79 Website marketing@dynamiker.com EUDAMED record Report an error
ELITechGroup Italy B, C IVDR, 98/79 Website EUDAMED record Report an error
Eurobio Scientific France – 98/79 reglementaire@eurobio-scientific.com EUDAMED record Report an error
Eurospital Italy – 98/79 regulatory@eurospital.it EUDAMED record Report an error
Human Germany – 98/79 Website EUDAMED record Report an error
Lifotronic EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 Website EUDAMED record Report an error
Meridian Bioscience EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States C IVDR Website EUDAMED record Report an error
Newmarket Biomedical EU representative : MDSS GmbH (Germany) United Kingdom (ex Northern Ireland) C IVDR, 98/79 Website regulatory@new-bio.com EUDAMED record Report an error
Quimica Clinica Aplicada Spain – 98/79 Website EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China – 98/79 EUDAMED record Report an error
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany) Russia – 98/79 Website EUDAMED record Report an error
Ab Analitica Italy – 98/79 customersupport@abanalitica.it EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@am-diagnostics.co.uk EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium) China – 98/79 EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Bioer EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR, 98/79 Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Bosonbio EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
CTK Biotech EU representative : MDSS GmbH (Germany) United States B, C IVDR Website info@ctkbiotech.com EUDAMED record Report an error
Denizbiyokimya Türkiye – 98/79 EUDAMED record Report an error
Dirui EU representative : Emergo Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Dyonmed Greece – 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website info@gensurebio.com EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
HEALSTONE Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) Canada – 98/79 sales@orientgene.com EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Ingenetix Austria – 98/79 Website office@ingenetix.com EUDAMED record Report an error
Kamiya Biomedical EU representative : Advena Limited (Malta) United States – 98/79 Website info@k-assay.com EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website info@khmedical.co.kr EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti Türkiye B IVDR, 98/79 Website info@koroglugroup.com EUDAMED record Report an error
Mpbio EU representative : MP Biomedicals Germany GmbH (Germany) Germany, Singapore – 98/79 Website EUDAMED record Report an error
Nanjing Synthgene Medical Technology EU representative : Lotus NL B.V. (Netherlands) and 1 other China C IVDR, 98/79 Website sales@syngenebio.com EUDAMED record Report an error
Pluslife EU representative : Medunion S.L. (Spain) and 1 other China C IVDR, 98/79 Website ra@pluslife.com EUDAMED record Report an error
Ravo Germany – 98/79 Website info@ravo.de EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@huiantech.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
Technogenetics Italy B, C IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Vivachek EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) China
14 others
 – 98/79 EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium) China C IVDR, 98/79 Website EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland) India C IVDR Website info@3bblackbio.com EUDAMED record Report an error
3D Biomedicine Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) 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
Aichek EU representative : Medunion S.L. (Spain) China – 98/79 ra.rep@aichek.com EUDAMED record Report an error
AIDA Germany – 98/79 EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye – 98/79 Website info@anatoliagenetik.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
Becton Dickinson EU representative : Becton Dickinson Ireland Limited (Ireland) United States B, C IVDR Website EUDAMED record Report an error
Biomerica EU representative : MDSS GmbH (Germany) United States – 98/79 Website info@biomerica.com EUDAMED record Report an error
Daltonbio EU representative : Medunion S.L. (Spain) China – 98/79 Website EUDAMED record Report an error
Diapro Italy – 98/79 Website info@diapro.it EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@fanttest.com EUDAMED record Report an error
FRIZ Biochem Germany B IVDR Website info@frizbiochem.de 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
Guangzhou Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Hybribio EU representative : Kingsmead Service B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website info@kogene.co.kr EUDAMED record Report an error
Lysunbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Operon Spain B IVDR, 98/79 Website infoeudamed@operon.es EUDAMED record Report an error
PathoFinder Netherlands – 98/79 Website info@pathofinder.com EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website EUDAMED record Report an error
Rocgene EU representative : Medunion S.L. (Spain) China – 98/79 sale@rocgene.com EUDAMED record Report an error
Seegene EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR, 98/79 Website info@seegene.com EUDAMED record Report an error
Sejoy EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Umedwings Netherlands B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 Website info@orienterglobal.com EUDAMED record Report an error
Siemens Healthcare Diagnostics EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States – 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United Kingdom (ex Northern Ireland) B, C IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 sales@singuway.com EUDAMED record Report an error
SpeeDx EU representative : MedEnvoy Global BV (Netherlands) Australia C IVDR Website regulatory@speedx.com.au EUDAMED record Report an error
Tianjin Bioscience Diagnostic Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 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
Vitro Romania B IVDR Website office@vitro.ro EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium) China – 98/79 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
Zetmedikal Türkiye – 98/79 Website info@zetmedikal.com EUDAMED record Report an error
ZEUS Scientific EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website regulatory@zeusscientific.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) China
5 others
 – 98/79 EUDAMED record Report an error
-Diagnostics EU representative : mdi Europa GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Sungo Cert GmbH (Germany) China – 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
Adaltis Italy – 98/79 Website info@adaltis.net EUDAMED record Report an error
Anchor Diagnostics Germany – 98/79 info@anchor-diagnostics.com EUDAMED record Report an error
AVE Science & Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
Beijing Kewei Clinical Diagnostic Reagent EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Bio-Novum Poland – 98/79 Website EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain) China – 98/79 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
BioGX Netherlands – 98/79 Website EUDAMED record Report an error
Biohit Finland – 98/79 Website info@biohit.fi EUDAMED record Report an error
Biosystems Spain – 98/79 Website EUDAMED record Report an error
Campmedica Romania – 98/79 Website EUDAMED record Report an error
Cepheid EU representative : Cepheid AB (Sweden) Sweden, United States C IVDR, 98/79 Website EUDAMED record Report an error
Cesna Türkiye B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 sales@coyotebio.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 service@credodxbiomed.com EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Diagenode Belgium B IVDR info@diagenode.com EUDAMED record Report an error
Eiken EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany) Japan C IVDR regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
Elisabeth Czechia – 98/79 Website info@elisabeth.cz EUDAMED record Report an error
GeneMatrix EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website support@genematrix.net EUDAMED record Report an error
Genemind EU representative : Medunion S.L. (Spain) China – 98/79 regulatoryaffairs@genemind.com EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website ra@genetree.co.kr EUDAMED record Report an error
Genhawk (Wuhan) Biotech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Geratherm Germany – 98/79 Website info@geratherm.com EUDAMED record Report an error
Hangzhou New Horizon Health Technology EU representative : MedPath GmbH (Germany) and 1 other China C IVDR, 98/79 Website compliance@nhbio.com.cn EUDAMED record Report an error
Hotgen EU representative : MedNet EC-REP GmbH (Germany) China C IVDR service@hotgen.com.cn EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China C IVDR, 98/79 support@igenesisbio.com EUDAMED record Report an error
Iontek Türkiye – 98/79 Website EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Leadmanbio EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
Linear Spain – 98/79 Website info@linear.es EUDAMED record Report an error
Livzondiagnostics EU representative : QbD RepS BV (Belgium) China C IVDR Website ra@livzondiagnostics.com EUDAMED record Report an error
MedicalSystem Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Microprofit EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 EUDAMED record Report an error
Mindray EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China B IVDR Website EUDAMED record Report an error
Moelab Germany – 98/79 Website info@moelab.de EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany) China – 98/79 EUDAMED record Report an error
Nuclear Laser Medicine Italy C IVDR Website quality@nlm.it EUDAMED record Report an error
Oxford Immunotec EU representative : Wallac Oy (Finland) United Kingdom (ex Northern Ireland) C IVDR regulatory.oxford@revvity.com EUDAMED record Report an error
Phasescientific EU representative : CMC Medical Devices & Drugs SL (Spain) Hong Kong SAR China – 98/79 Website info@phasesci.com EUDAMED record Report an error
Pro-Lab Diagnostics UK EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
Qiagen Germany C IVDR Website info@qiagen.com EUDAMED record Report an error
Reagena Finland – 98/79 Website info@reagena.com EUDAMED record Report an error
Remel EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Roche Germany C IVDR Website EUDAMED record Report an error
Serosep Ireland – 98/79 Website info@serosep.com EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR EUDAMED record Report an error
Shenzhen Freecom Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China B IVDR Website EUDAMED record Report an error
Tianjin Jianbo Biological EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Tosoh EU representative : Tosoh Europe N.V. (Belgium) Japan – 98/79 csc@tosoh.co.jp EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 sales@ukinbio.com EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Xenta Biomedical Science EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium) China – 98/79 Website EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market Egypt
11 others
 – 98/79 Website info@vitroscient.com EUDAMED record Report an error
Uniogen No model still on the market Finland – 98/79 info@uniogen.com EUDAMED record Report an error
Nantong EgensBiotechnology EU representative : SUNGO Europe B.V. (Netherlands) and 1 other No model still on the market China – 98/79 qa@egens-bio.cn EUDAMED record Report an error
Princeton BioMeditech EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market United States – 98/79 Website info@pbmc.com 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
Chemelex No model still on the market Spain – 98/79 Website EUDAMED record Report an error
Deben Diagnostics EU representative : EU-UK Authorised Representative Ltd (Northern Ireland) No model still on the market United Kingdom (ex Northern Ireland) – 98/79 Website info@debendiagnostics.co.uk EUDAMED record Report an error
Mobidiag No model still on the market Finland – 98/79 Website sales.mob@hologic.com EUDAMED record Report an error
IDL Biotech No model still on the market Sweden – 98/79 Website EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market Egypt – 98/79 Website info@nsbiotec.com EUDAMED record Report an error

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