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IVD instrumentsGeneral purpose IVD instrumentsVarious general purpose IVD instruments

Various general purpose IVD instruments - IVD medical device software

EMDN code W02079092

44 manufacturers, 78 models including 75 on the market, 15 countries

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Manufacturers registered in Europe (EUDAMED) 44
  • 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
Dedalus Italy
4 others
 A IVDR EUDAMED record Report an error
MAK-SYSTEM Group FDA EU representative : AR Experts B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR regulatory@mak-system.net EUDAMED record Report an error
Tesi Elettronica e Sistemi Informativi Italy A IVDR Website mail@tesigroup.tech EUDAMED record Report an error
Fujirebio FDA Belgium A IVDR Website 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
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United Kingdom (ex Northern Ireland) – 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
SmartSeq Italy – 98/79 Website info@smartseq.it EUDAMED record Report an error
Wallac Finland C IVDR, 98/79 Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Health in Code Spain – 98/79 Website EUDAMED record Report an error
LaCAR MDx Technologies FDA Belgium A IVDR Website EUDAMED record Report an error
MetaSystems Hard & Software Germany A IVDR Website info@metasystems-international.com EUDAMED record Report an error
Mylab Finland – 98/79 Website EUDAMED record Report an error
Oxford Cancer Biomarkers EU representative : CEpartner4U (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore, United States A, C IVDR Website info.dk@agilent.com EUDAMED record Report an error
Advanced Marker Discovery Spain – 98/79 Website info@amadix.com EUDAMED record Report an error
Aesku FDA Germany A IVDR Website EUDAMED record Report an error
Affymetrix EU representative : Life Technologies Europe B.V. (Netherlands) United States C IVDR EUDAMED record Report an error
Astraia Germany C IVDR Website info@astraia.com EUDAMED record Report an error
Benetech EU representative : MDSS GmbH (Germany) Canada – 98/79 Website info@benetech.com EUDAMED record Report an error
Cellbytes Finland A IVDR Website EUDAMED record Report an error
Certest Spain A IVDR Website quality@certest.es EUDAMED record Report an error
Corista EU representative : CMC Medical Devices & Drugs SL (Spain) United States A IVDR Website EUDAMED record Report an error
Dasit Italy A IVDR EUDAMED record Report an error
Euformatics Finland – 98/79 Website contact@euformatics.com EUDAMED record Report an error
Euroimmun FDA Germany A IVDR Website info@euroimmun.de EUDAMED record Report an error
Fagron Genomics Spain C IVDR Website EUDAMED record Report an error
Genetron (Wuxi) Biotech EU representative : MedPath GmbH (Germany) China – 98/79 EUDAMED record Report an error
GenomeUp Italy A IVDR EUDAMED record Report an error
Hartwig Medical Foundation Netherlands C IVDR Website info@hartwigmedicalfoundation.nl EUDAMED record Report an error
Intelligence Artificielle Applications France – 98/79 Website EUDAMED record Report an error
JSI medical systems Germany C IVDR Website mail@jsi-medisys.de EUDAMED record Report an error
Limbus Medical Technologies Germany C IVDR Website info@limbus-medtec.com EUDAMED record Report an error
Mikrogen Germany – 98/79 EUDAMED record Report an error
NGeneBio EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea – 98/79 Website EUDAMED record Report an error
PathAI FDA EU representative : MDSS GmbH (Germany) United States A IVDR EUDAMED record Report an error
Philips FDA Netherlands – 98/79 eudamed@philips.com EUDAMED record Report an error
Proscia FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
RAM THz Solutions Germany – 98/79 Website info@ramthzsolutions.com EUDAMED record Report an error
Sbp Soft 2007 Spain – 98/79 Website info@sbpsoftware.com EUDAMED record Report an error
Sensetime EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
SPD Swiss Precision Diagnostics FDA EU representative : MDSS GmbH (Germany) Switzerland B IVDR EUDAMED record Report an error
Spotlab Spain – 98/79 Website info@spotlab.org EUDAMED record Report an error
Viseur Türkiye A IVDR EUDAMED record Report an error
Visia Lab FDA Italy A IVDR Website quality@visialab.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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