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Emdyca

Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsCardiography instruments

Cardiography instruments - hardware accessories

EMDN code Z12050780

2 manufacturers, 3 models including 3 on the market, 2 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
Abbott FDA EU representative : Abbott Medical (Belgium) United States I, IIb MDR EUDAMEDInq_EP@abbott.com EUDAMED record Report an error
Biotronik FDA Germany IIb MDR Website info@biotronik.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) 4

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
St Jude Medical United States EP-4™ WorkMate Claris™ registered
Fischer Medical United States Bloom2 Bloom K173439 (2018)
MICROPACE PTY LIMITED Present in Europe in other categories Australia Micropace MICROPACE PTY LIMITED ORLAB StimLab K072200 (2007)
Medtronic, Inc. Present in Europe in other categories United States – registered

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