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Emdyca

IVD instrumentsMicrobiology instruments (cultures)Various microbiology instruments

Various microbiology instruments - consumables

EMDN code W02039085

6 manufacturers, 31 models including 31 on the market, 5 countries

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Manufacturers registered in Europe (EUDAMED) 6
  • 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
bioMérieux FDA EU representative : bioMérieux SA (France) France, United States
9 others
 A IVDR EUDAMED record Report an error
Diagnostic Consulting Network FDA EU representative : MediMark Europe Sarl. (France) United States
2 others
 – 98/79 Website EUDAMED record Report an error
Beckman Coulter FDA Ireland A IVDR Website ra.clare@beckman.com 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
Bruker FDA Germany A IVDR Website info.md@bruker.com EUDAMED record Report an error
Trek Diagnostic Systems EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website 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) 1

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
Bruker Daltonik GmbH Germany MBT Pilot System - US IVD MALDI Biotyper sirius CA System MALDI Biotyper-BD sirius CA System MALDI Biotyper CA System MALDI Biotyper-BD sirius one CA System MALDI Biotyper sirius one CA System K163536 (2017)

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