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Emdyca

Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instruments

Cardiac telemetry instruments

EMDN code Z120508

9 manufacturers, 13 models including 13 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 9
  • 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
SHL Telemedicine International FDA EU representative : SHL Telemedizin GmbH (Germany) Israel IIa 93/42 Website info@shl-telemedicine.com EUDAMED record Report an error
Philips FDA EU representative : Philips Medizin Systeme Böblingen GmbH (Germany) United States IIb 93/42 eudamed@philips.com EUDAMED record Report an error
Pooyandegan rah saadat EU representative : Trionara Technologies AB (Sweden) Iran IIb MDR Website EUDAMED record Report an error
CardiacSense FDA EU representative : MedNet EC-REP GmbH (Germany) Israel IIa MDR Website EUDAMED record Report an error
Emtel Poland IIb 93/42 Website EUDAMED record Report an error
Health Care Systems Germany IIa MDR EUDAMED record Report an error
Kardi Czechia IIa MDR Website EUDAMED record Report an error
Norav FDA EU representative : Norav Medical GmbH (Germany) Germany, Israel IIa MDR Website info@norav.com EUDAMED record Report an error
VitalConnect FDA EU representative : MDSS GmbH (Germany) United States IIa 93/42 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
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)
Biotronik, Inc. Present in Europe in other categories United States BioMonitor III BioMonitor IV BioMonitor IIIm BioMonitor Remote Assistant III K261074 (2026)
St Jude Medical United States Merlin.net™ Assert-IQ™ registered
ABBOTT MEDICAL Present in Europe in other categories United States – K253516 (2025)
Abbott Laboratories Present in Europe in other categories United States – K251221 (2025)

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