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Emdyca

ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Syphilis (treponema pallidum)

EMDN code W01050103

84 manufacturers, 198 models including 191 on the market, 15 countries

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Manufacturers registered in Europe (EUDAMED) 84
  • 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
10 others
 C IVDR, 98/79 Website info@euroimmun.de EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
5 others
 – 98/79 Website info@testlinecd.com EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland) United States
2 others
 – 98/79 Website EUDAMED record Report an error
Dialab Austria
1 other
 – 98/79 Website office@dialab.at EUDAMED record Report an error
Mikrogen Germany
1 other
 C IVDR, 98/79 EUDAMED record Report an error
Viramed FDA Germany
1 other
 C IVDR Website EUDAMED record Report an error
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Bio-Rad FDA France C IVDR, 98/79 Website contact@bio-rad.com EUDAMED record Report an error
Vircell Spain – 98/79 EUDAMED record Report an error
Vitrosens Türkiye C IVDR, 98/79 Website info@vitrosens.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
Giesse Diagnostics Italy – 98/79 Website info@giessediagnostics.com EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 Website EUDAMED record Report an error
Newmarket Biomedical FDA EU representative : MDSS GmbH (Germany) United Kingdom (ex Northern Ireland) C IVDR, 98/79 Website regulatory@new-bio.com EUDAMED record Report an error
Sanymed Italy – 98/79 Website info@sanymed.it EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) 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
Denizbiyokimya Türkiye – 98/79 EUDAMED record Report an error
Diesse FDA Italy C IVDR Website EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany) Egypt – 98/79 Website info@spectrum-diagnostics.com EUDAMED record Report an error
Geneproof Czechia – 98/79 Website support@geneproof.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China – 98/79 info@alltests.com.cn EUDAMED record Report an error
Spinreact Spain – 98/79 Website EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium) China – 98/79 EUDAMED record Report an error
Diapro Italy – 98/79 Website info@diapro.it EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India – 98/79 Website EUDAMED record Report an error
Genesignbio EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 info@genesignbio.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China C IVDR, 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
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Lorne Laboratories EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@lornelabs.com EUDAMED record Report an error
LTA Italy – 98/79 Website office@ltaonline.it EUDAMED record Report an error
Seramun Germany – 98/79 info@seramun.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States – 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Tianjin Bioscience Diagnostic Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
ZEUS Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website regulatory@zeusscientific.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States – 98/79 info@acrobiotech.com EUDAMED record Report an error
Adaltis Italy – 98/79 Website info@adaltis.net EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) China – 98/79 ra.rep@aichek.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 sales@dbluemedical.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 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
Bio-Novum Poland – 98/79 Website EUDAMED record Report an error
BioGX FDA Netherlands – 98/79 Website EUDAMED record Report an error
Biosystems FDA Spain – 98/79 Website EUDAMED record Report an error
Bosonbio FDA EU representative : MedPath GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Chronolab Spain – 98/79 Website info@chronolab.com EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany) United States C IVDR Website info@ctkbiotech.com EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Diagnostics Belgium – 98/79 Website EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain) China C IVDR Website info@diagreat.com EUDAMED record Report an error
Ecolidx Czechia – 98/79 Website 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 Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@jgbiotech.com EUDAMED record Report an error
Hotgen FDA EU representative : MedNet EC-REP GmbH (Germany) China C IVDR service@hotgen.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
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium) China – 98/79 Website EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany) Egypt – 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 FDA Spain – 98/79 Website info@linear.es EUDAMED record Report an error
Livzondiagnostics FDA EU representative : QbD RepS BV (Belgium) China C IVDR Website ra@livzondiagnostics.com EUDAMED record Report an error
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 Website EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China B IVDR 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
Sansure FDA EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website info@szyhlo.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United Kingdom (ex Northern Ireland) C IVDR Website contact@siemens-healthineers.com 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
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany) China – 98/79 sales@syngenebio.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website service@bioustar.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 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
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
Biotime EU representative : Medunion S.L. (Spain) No model still on the market China – 98/79 EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) 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.

Other manufacturers known in the United States (FDA) 19

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
CLARK LABORATORIES, INC. United States Trinity Biotech Phoenix Biotech BIO-RAD Bio-Stat registered
Abbott Laboratories Present in Europe in other categories United States ARCHITECT Alinity K153730 (2016)
Roche Diagnostics Corp. Present in Europe in other categories United States Elecsys Syphilis K211302 (2021)
MARDX DIAGNOSTICS, INC. United States Trinity Biotech registered
Quest Intl., Inc. United States SeraQuest ReQuest registered
Beckman Coulter, Inc. Present in Europe in other categories United States Access Syphilis Reagent K241427 (2024)
Chembio Diagnostic Systems Inc. United States DPP HIV-Syphilis registered
DiaSorin, Inc. Present in Europe in other categories United States LIAISON® Treponema Assay K061247 (2006)
FUJIREBIO INC. Present in Europe in other categories – Lumipulse G TP-N Immunoreaction Cartridges Set registered
Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories United States VITROS K241534 (2024)
VEDALAB France Syphilis Health Check registered
ARLINGTON SCIENTIFIC, INC. United States – registered
BIOCHECK, INC. United States – registered
Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti Türkiye – registered
Diagnostic Automation /Cortez Diagnostics Inc. United States – registered
Diagnostics Direct, LLC United States – K102400 (2011)
Fujirebio Diagnostics,Inc. Present in Europe in other categories United States – K153145 (2016)
QuidelOrtho Corporation United States – registered
Roche Diagnostics Operations Inc. United States – registered

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