Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instruments
Various instruments for cardiology and cardiac surgery
EMDN code Z120590
Manufacturers registered in Europe (EUDAMED) 29
- 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.
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) 170
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| St Jude Medical | United States | EnSite™ MediGuide™ WorkMate Claris™ EnSite Precision™ PressureWire™ Ampere™ | P960016 (2026) |
| Boston Scientific Corp Present in Europe in other categories | United States | RHYTHMIA HDx™ iLab Ultrasound Imaging System Rhythmia™ Mapping System AVVIGO™+ AVVIGO™ Guidance System II iLab™ | K253692 (2026) |
| IRVINE BIOMEDICAL, INC. | – | Therapy™ SJM™ Cool Point™ Safire™ TX Safire™ Duo MediGuide Enabled™ | P040014 (2026) |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | MAC Mac-Lab CAM CASE CardioSoft | K243540 (2024) |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Pathfinder SL Sentinel PathfinderSL Sentinal Lifescreen Pro | registered |
| Edwards Lifesciences, LLC Present in Europe in other categories | United States | HemoSphere Vita HemoSphere HemoSphere Alta EV1000 Acumen IQ Sensor with Fluid Meter | K253186 (2026) |
| ZURICH MEDICAL INC. | United States | Zurich Medical Accessory Cable Zurich Pressure Guidewire System | registered |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | – | Safire™ Livewire™ Livewire TC™ | registered |
| BIOSIG TECHNOLOGIES, INC. | United States | Pure EP - Catheter Input Module Pure EP - 5 x 10 pin Yoked Jumper Cable White Pure EP Pure EP - 5 x 4 pin Yoked Jumper Cable Red Pure EP - 5 x Single Jumper Cable Red 0.3m Pure EP - ECG Cable | K180805 (2018) |
| Innovision A/S | United States | Innocor | K071911 (2007) |
| Centerline Biomedical, Inc. | United States | IOPS Viewpoint IOPS™ IOPS® IOPS Visionary System IOPS Mobile Cart IOPS™ Software Application | K263016 (2026) |
| EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | – | Cardio Server Epiphany Cardio Server | registered |
| Itamar Medical , Ltd. Present in Europe in other categories | Israel | Endo PAT 2000 EndoPATx 12 Pneumatic Endo probes for Endo PAT 2000 Accessories, EndoPATx Anchors(30) for Endo PAT 2000 Accessories for Endo PAT 2000 | K211557 (2022) |
| Mortara Instrument, Inc. | United States | Vision Express HeartCentrix Pyramis Holter Prep Kit | K161465 (2016) |
| Cardio Tek, BV | United States | EP-TRACER Adapter cables unipolar/ bipolar (set of 10) Aluminium carrying case | K161245 (2016) |
| D. E. Hokanson, Inc. Present in Europe in other categories | United States | Hokanson | K970570 (1997) |
| Mennen Medical, Inc. | United States | EMS-XL Horizon XVu | K091165 (2009) |
| Icentia Inc. | Canada | CardioSTAT EART | registered |
| Kardium Inc | Canada | Globe Positioning System (GPS™) Cable Globe® Controller Globe® Workstation Globe Positioning System (GPS™) Electrodes Globe® Catheter Globe® PF Generator | P240044 (2026) |
| MICROPORT CRM SRL Present in Europe in other categories | United States | EASYSCOPE SYNESCOPE SYNECOM | registered |
| Vektor Medical, Inc. | United States | vMap Control Unit vMap Disposables Vektor Medical vMap Software | K252429 (2025) |
| COROVENTIS Research AB Present in Europe in other categories | Sweden | CoroFlow Upgrade kit CoroFlow CoroFlow Cardiovascular System CoroFlow PPG Software CoroFlow TouchPad | K252238 (2025) |
| Cortex, Inc. Present in Europe in other categories | – | OptiMap™ System - NA OptiMap Cart OptiMap Monitor OptiMap™ Workstation OptiMap Amplifer | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. Cardio Server | registered |
| ATsens Co., Ltd. Present in Europe in other categories | South Korea | AT-Patch ATACC-C130A AT-Report | registered |
| CHANGE HEALTHCARE ISRAEL LTD | Israel | Change Healthcare Cardiology ECG Management Change Healthcare Cardiology Hemo | registered |
| Getemed Medizin- Und Informationstechnik AG Present in Europe in other categories | United States | CardioDay CardioDay V 2.5 CardioDay V2.5 | K162023 (2017) |
| North East Monitoring, Inc. | United States | Holter Analysis Software | K930564 (1995) |
| PREMIER HEART, LLC | United States | Premier Heart MCG Analysis Software Premier Heart MCG Premier Heart MCG Analysis API Premier Heart MCG Model VH12 | K992703 (2000) |
| Philips Medical Systems Hsg | – | IECG Philips Stress | registered |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | Sensis Vibe Combo Sensis Vibe Hemo Sensis Lite Sensis | registered |
| Cardiac Insight, Inc. | United States | Cardea SOLO | registered |
| Cardiocalm Srl | Italy | CER-S | K243312 (2025) |
| Catheter Precision, Inc. | United States | VIVO Positioning Patches VIVO System VIVO | K261886 (2026) |
| INSIGHTRA MEDICAL, INC. | United States | Ultra IABP Catheter Kit | K082746 (2009) |
| MERGE HEALTHCARE SOLUTIONS INC. Present in Europe in other categories | – | Merge Hemo Merge Hemo Link Assembly | registered |
| Medicalgorithmics S.A. Present in Europe in other categories | Poland | DeepRhythmAI DeepRhythm Platform | K253141 (2025) |
| OSYPKA GmbH | Germany | MAGIC - iCONNECT MAGiC Magnetic Interventional Ablation Catheter iCONNECT - AMPERE | registered |
| The Atlanta Dental Supply Company | – | Advance Dental Products | registered |
| Analytics for Life Inc. | United States | CorVista® System CorVista® System with CAD Add-On | K253576 (2026) |
| Avante | – | Sage 12c Waveline VS | registered |
| Cardionxt Inc | United States | iMap Software iMap 3D Mapping and Navigation System | K201094 (2021) |
| Medtronic Cryocath, LP | – | – | P020045 (2026) |
| SCOTTCARE CORPORATION, THE | United States | HolterCare Editing Kit HolterCare | registered |
| SUBSTRATE HD Present in Europe in other categories | – | Volta AF-Xplorer II Volta AF-Xplorer | registered |
| iRhythm Technologies, Inc. | United States | Zio ECG Utilization Software (ZEUS) System ZIO AT Patch | K252859 (2026) |
| APN HEALTH | United States | Navik 3D | K152160 (2016) |
| Ablacon Inc. | United States | Ablamap® System | K230008 (2023) |
| BIOFOURMIS SINGAPORE PTE. LTD. | Singapore | RhythmAnalytics | K182344 (2019) |
| CARDIOLOGS TECHNOLOGIES | France | Cardiologs Platform | registered |
| Cath Vision Aps | Denmark | ECGenius System | K223787 (2023) |
| Endothelix, Inc. | United States | VENDYS II | K072919 (2007) |
| FUJIFILM Healthcare Americas Corporation Present in Europe in other categories | United States | Synapse Select | registered |
| GALT MEDICAL CORP. | – | Guidewire | registered |
| Implicity, Inc. Present in Europe in other categories | United States | ILR ECG Analyzer | K253463 (2026) |
| Imricor Medical Systems, Inc. | United States | NorthStar Mapping System | K261119 (2026) |
| LIGHTLAB IMAGING, INC. | – | Ultreon™ | registered |
| Lumedx Corporation | United States | HealthView ECG Manager | K123466 (2012) |
| MICROPACE PTY LIMITED Present in Europe in other categories | Australia | MICROPACE PTY LIMITED | K253088 (2026) |
| Rhythm AI, Ltd. | United Kingdom | STAR Apollo | K263380 (2026) |
| SAFEBEAT RX INC. | United States | SafeBeat Rx App | K251218 (2026) |
| SMART SOLUTIONS TECHNOLOGIES SL | Spain | Nuubo System | K231620 (2023) |
| AMC | United States | – | registered |
| ARMM INC. | United States | – | registered |
| ATL Technology LLC | United States | – | registered |
| Abbott Electrophysiology | United States | – | K171583 (2017) |
| Accurkardia, Inc. | United States | – | registered |
| Acutus Medical, Inc. | United States | – | K231091 (2023) |
| Airgas Therapeutics, LLC Present in Europe in other categories | United States | – | registered |
| AliveCor, Inc. Present in Europe in other categories | United States | – | K212662 (2022) |
| Amphenol Alden Products Company | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Amphenol DC Electronics | Mexico | – | registered |
| Anumana, Inc. | United States | – | K233160 (2023) |
| Arrow International, Teleflex | United States | – | K192238 (2019) |
| Arrow Intl., Inc. | United States | – | K250542 (2025) |
| B-Secur Limited | United Kingdom | – | K233755 (2024) |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | – | registered |
| Boulder BioMed dba Boulder iQ | United States | – | registered |
| C.R. Bard, Inc. | United States | – | registered |
| CARRIO CABLING CORPORATION | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | – | registered |
| Cardioinsight Technologies, Inc. | United States | – | K162440 (2016) |
| Carefusion Germany 234 GmbH | Germany | – | K153654 (2016) |
| ClearPath Medical, LLC | United States | – | registered |
| Conmed Corporation Present in Europe in other categories | United States | – | registered |
| Corify Care S.L | Spain | – | K253861 (2026) |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Creation Technologies | Canada | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DOLPHIN LIFE SCIENCE (INDIA) LLP | India | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| DT Research, Inc. | United States | – | registered |
| Dedicated Computing LLC | United States | – | registered |
| Dreamtech co., ltd. | South Korea | – | registered |
The 100 most active manufacturers are shown, out of 170.
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Related categories
- Electrocardiographs77 manufacturers
- Holter system instruments for cardiovascular parameters52 manufacturers
- Cardiography instruments12 manufacturers
- Cardiac telemetry instruments9 manufacturers
- Stress analysis instruments9 manufacturers
- Extra-corporeal circulation instruments7 manufacturers
- Cardiac output measurement instruments5 manufacturers
- Non-implantable cardiac stimulators3 manufacturers
- Parent category : Cardiology and cardiosurgery instruments166 manufacturers