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Emdyca

IVD instrumentsMicrobiology instruments (cultures)Various microbiology instruments

Various microbiology instruments - hardware accessories

EMDN code W02039080

3 manufacturers, 6 models including 5 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 3
  • 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
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Bd FDA Netherlands A IVDR Website EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium) No model still on the market China
  • SW (no longer marketed)
 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) 5

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
HARDY DIAGNOSTICS United States – registered
Becton, Dickinson & CO Present in Europe in other categories United States BD BBL™ Venting Unit BD BACTEC™ Subculturing/Aerobic Venting Unit registered
Roche Diagnostics Corp. Present in Europe in other categories United States cobas® Microbial Inactivation Solution registered
Roche Diagnostics Operations Inc. United States – registered
bioMerieux, Inc. Present in Europe in other categories United States – registered

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