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Emdyca

Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instruments

Cardiography instruments

EMDN code Z120507

12 manufacturers, 20 models including 20 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 12
  • 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, 93/42 EUDAMEDInq_EP@abbott.com EUDAMED record Report an error
Masimo FDA EU representative : MDSS GmbH (Germany) United States I, IIb MDR Website customerorders@masimo.com EUDAMED record Report an error
GE Medical Systems Information Technologies FDA EU representative : GE Medical Systems SCS (France) United States IIa MDR eudamed@gehealthcare.com EUDAMED record Report an error
Siemens Healthcare FDA Germany IIb MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Siemens Healthineers FDA Germany IIb MDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Substrate HD France IIa MDR Website contact@volta-medical.com EUDAMED record Report an error
Biotronik FDA Germany IIb MDR Website info@biotronik.com EUDAMED record Report an error
Cnsystems FDA Austria IIa MDR Website office@cnsystems.com EUDAMED record Report an error
Fysicon FDA Netherlands IIb MDR Website info@fysicon.com EUDAMED record Report an error
Mdoloris FDA France IIa MDR Website EUDAMED record Report an error
metek Medizin Technik Komponenten Germany IIb MDR, 93/42 EUDAMED record Report an error
Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny Poland IIa MDR 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
St Jude Medical United States EP-4™ WorkMate Claris™ Merlin.net™ Assert-IQ™ registered
Boston Scientific Corp Present in Europe in other categories United States myLUX™ Patient App myLUX™ Patient Kit with mobile device LUX-Dx™ Clinic Assistant Kit with mobile device LUX-Dx™ Clinic Assistant Mobile Device LUX-Dx II+™ myLUX™ K252593 (2025)
Medtronic, Inc. Present in Europe in other categories United States AccuRhythm™ AI LINQ II™ Reveal LINQ™ CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) Application CareLink SmartSync™ LINQ II™ Platform Application K262735 (2026)
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)

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