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Emdyca

Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsVarious instruments for cardiology and cardiac surgery

Cardiac ablation equipment

EMDN code Z12059011

7 manufacturers, 21 models including 21 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 7
  • 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
Stockert FDA Germany
6 others
I, IIa, IIb MDR, 93/42 Website info@stockert.de EUDAMED record Report an error
Abbott FDA EU representative : Abbott Medical (Belgium) United States I, IIb MDR, 93/42 EUDAMEDInq_EP@abbott.com EUDAMED record Report an error
Biosense Webster FDA EU representative : Biosense Webster A Division of Johnson & Johnson Medical NV/SA (Belgium) United States IIb MDR EUDAMED_Enquiries@its.jnj.com EUDAMED record Report an error
AtriCure FDA EU representative : AtriCure Europe B.V. (Netherlands) United States I MDR Website EUDAMED record Report an error
Medpulses EU representative : MicroPort Medical B.V. (Netherlands) China IIb MDR EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands) United States IIb MDR EUDAMED record Report an error
Synapticmed FDA EU representative : MDSS GmbH (Germany) United States IIb 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) 34

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 Blazer® II Blazer® II HTD Blazer Prime® HTD Maestro 4000™ Pod, 100W Maestro 4000™ Controller IntellaNav™ ST P150005 (2025)
St Jude Medical United States Ampere™ FlexAbility™ Sensor Enabled™ Current™ Volt™ Volt™ PFA Sensor Enabled™ P960016 (2026)
IRVINE BIOMEDICAL, INC. – Therapy™ SJM™ Cool Point™ Safire™ TX Safire™ Duo MediGuide Enabled™ P040014 (2026)
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION – Safire™ Livewire™ Livewire TC™ registered
Kardium Inc Canada Globe® Catheter Globe® PF Generator Globe® Catheter Cable P240044 (2026)
OSYPKA GmbH Germany MAGIC - iCONNECT MAGiC Magnetic Interventional Ablation Catheter iCONNECT - AMPERE registered
Medtronic Cryocath, LP – – P020045 (2026)
AMC United States – registered
ARMM INC. United States – registered
ATL Technology LLC United States – registered
Amphenol Alden Products Company United States – registered
Amphenol DC Electronics Mexico – registered
C.R. Bard, Inc. United States – registered
CARRIO CABLING CORPORATION United States – registered
Covidien, LLC Present in Europe in other categories United States – registered
Creation Technologies Canada – registered
DSV Contract Logistics Mexico – registered
FOXCONN BAJA CALIFORNIA S.A DE C.V. Mexico – registered
Farapulse, Inc. Present in Europe in other categories – – P230030 (2026)
Flextronics International USA, Inc. United States – registered
HARMAC MEDICAL PRODUCTS, INC. United States – registered
Irvine Biomedical,Inc.(Ibi) – – P040042 (2026)
Jabil Inc. United States – registered
Lake Region Medical United States – registered
Linemaster Switch Corp. United States – registered
Merit Medical Systems, Inc. Present in Europe in other categories United States – registered
Molex (Thailand) Limited United States – registered
Nissha Medical Technologies Present in Europe in other categories United States – registered
PLEXUS CORP. United States – registered
Phillips-Medisize A/S Present in Europe in other categories United States – registered
Sanmina Corporation United States – registered
Stellartech Research Corp. United States – registered
Stereotaxis, Inc. Present in Europe in other categories United States – P240014 (2026)
TECHNICAL SERVICES FOR ELECTRONICS, INC. United States – registered

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