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Emdyca

ReagentsInfectious diseasesBacteriology (infect. immunology/NAT)

Other bacteriology immunoassays

EMDN code W01050117

57 manufacturers, 335 models including 326 on the market, 16 countries

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Manufacturers registered in Europe (EUDAMED) 57
  • 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
Gold Standard Diagnostics FDA Germany
39 others
 – 98/79 Website info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
31 others
 B IVDR, 98/79 Website info@testlinecd.com EUDAMED record Report an error
Vircell Spain
24 others
 B IVDR, 98/79 EUDAMED record Report an error
Euroimmun FDA Germany
15 others
 – 98/79 Website info@euroimmun.de EUDAMED record Report an error
Atlas Medical FDA Germany
10 others
 – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
7 others
 – 98/79 info@alltests.com.cn EUDAMED record Report an error
Chronolab Spain
6 others
 – 98/79 Website info@chronolab.com EUDAMED record Report an error
VMRD FDA EU representative : MediMark Europe Sarl. (France) United States
5 others
 – 98/79 Website EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany) Egypt
4 others
 – 98/79 Website info@spectrum-diagnostics.com EUDAMED record Report an error
Mikrogen Germany
4 others
 – 98/79 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
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
1 other
 – 98/79 Website EUDAMED record Report an error
Diagnostics Belgium
1 other
 – 98/79 Website EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) Italy, United States
1 other
 B IVDR, 98/79 Website ivdr_dsm@diasorin.com EUDAMED record Report an error
Lorne Laboratories EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
1 other
 – 98/79 Website info@lornelabs.com EUDAMED record Report an error
Sanymed Italy
1 other
 – 98/79 Website info@sanymed.it EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany) Egypt
1 other
 – 98/79 Website EUDAMED record Report an error
Viramed FDA Germany
1 other
 B IVDR Website EUDAMED record Report an error
Dialab Austria – 98/79 Website office@dialab.at EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia – 98/79 Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Biosynex France – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Orgentec Germany – 98/79 Website EUDAMED record Report an error
Quimica Clinica Aplicada Spain – 98/79 Website EUDAMED record Report an error
Seramun Germany – 98/79 info@seramun.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
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States – 98/79 quality@healgen.com EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany) Egypt – 98/79 EUDAMED record Report an error
LTA Italy – 98/79 Website office@ltaonline.it EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Remel Europe FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website contact@diareagent.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Fortress Diagnostics Northern Ireland – 98/79 Website info@fortressdiagnostics.com EUDAMED record Report an error
Giesse Diagnostics Italy – 98/79 Website info@giessediagnostics.com EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@biotests.com.cn EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Spinreact Spain – 98/79 Website EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Bio-Rad FDA France C IVDR Website contact@bio-rad.com EUDAMED record Report an error
Diesse FDA Italy C IVDR Website EUDAMED record Report an error
Genhawk (Wuhan) Biotech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
IBL International Germany – 98/79 Website EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany) China – 98/79 Website 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
Ravo Germany – 98/79 Website info@ravo.de 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
Technogenetics FDA Italy C IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Tianjin Jianbo Biological EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 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
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Chemelex No model still on the market Spain – 98/79 Website 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
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
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

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) 7

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
MARDX DIAGNOSTICS, INC. United States Trinity Biotech registered
AMERICAN LABORATORY PRODUCTS COMPANY, LTD. United States Bordetella pertussis IgG ELISA registered
Becton, Dickinson & CO Present in Europe in other categories United States BD Difco™ Bordetella Pertussis Antigen registered
DRG Instruments Gesellschaft mit beschränkter Haftung – Bordetella pertussis IgG ELISA registered
DRG International Inc United States Bordetella pertussis IgG ELISA registered
BIOCHECK, INC. United States – registered
Suzhou TianLong Biotechnology Co., Ltd. Present in Europe in other categories China – registered

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