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Emdyca

Hematology / histology / cytology instrumentsFlow cytometry instrumentsCytoflowmeters

Cytoflowmeters - software accessories

EMDN code W0202040182

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

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Manufacturers registered in Europe (EUDAMED) 2
  • 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
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) Ireland, United States A IVDR Website ra.clare@beckman.com EUDAMED record Report an error
Cytognos FDA Spain – 98/79 Website direction@cytognos.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) 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
Becton, Dickinson & CO Present in Europe in other categories United States FACSCanto BD FACSuite FACS BD FACSLyric BD Multitest K201814 (2020)
Boule Diagnostics AB Present in Europe in other categories Sweden – registered
Flextronics International USA, Inc. United States – registered
STRATEC SE Present in Europe in other categories Germany – registered
STRATEC Switzerland AG c/o STRATEC SE Germany – registered

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