Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsElectrocardiographs
General purpose electrocardiographs
EMDN code Z12050301
Manufacturers registered in Europe (EUDAMED) 70
- 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) 76
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 |
|---|---|---|---|
| PROTEUS DIGITAL HEALTH, INC. | – | Proteus Digital Health Feedback System | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | PACEART® SYSTEM GET CONNECTED III PACEART OPTIMA™ SYSTEM PACEART® SYSTEM ECG MODULE PACEART® SYSTEM GET CONNECTED III, CardioVoice® TTM Assistant Software | registered |
| Universal Medical, Inc. | United States | eCardiostation Software Heartrak ECAT 2 Fusion Air Pacetrak Plus rev 4 Cardiostation® Advantage Software Heartrak Smart Rev 5 | K083535 (2008) |
| Analog Devices, Inc. | United States | SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) SENSINEL™ CPM BASE STATION SENSINEL™ CPM WEARABLE SENSINEL™ CPM ALIGNMENT TOOL SENSINEL™ CPM REPLACEMENT ADHESIVE PAD SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack) | registered |
| Lifewatch | – | LifeWatch Mobile Cardiac Telemetry 3-Lead LifeWatch Mobile Cardiac Telemetry 1 Lead Patch MicroER Explorer | registered |
| Bittium Biosignals Oy Present in Europe in other categories | Finland | Faros Bittium Faros 180 waterproof Faros 360 waterproof Bittium Faros | registered |
| SCOTTCARE CORPORATION, THE | United States | EZLink-R OneView EZLink EZLink-C Transtelephonic Receiving Module EventCare | K895719 (1990) |
| AliveCor, Inc. Present in Europe in other categories | United States | KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max Kardia Mobile K1000 KardiaMobile Card | K220350 (2022) |
| Qompium NV | Belgium | FibriCheck | K173872 (2018) |
| Shl Telemedicine International , Ltd. Present in Europe in other categories | Israel | smartheart CardioSen'C RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | K113514 (2012) |
| WITHINGS Present in Europe in other categories | France | Withings® | registered |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare Lifecard | registered |
| Vitalograph , Ltd. Present in Europe in other categories | United States | ECG | registered |
| Biotricity | United States | BIOFLUX | K172311 (2017) |
| Cardiocomm Solutions, Inc. | Canada | GEMS Mobile ECG HeartCheck CardiBeat | K181310 (2019) |
| Lifesignals, Inc. Present in Europe in other categories | United States | UbiqVue Holter UbiqVue | registered |
| VIVAQUANT, INC. | United States | Rhythm Express | K183704 (2019) |
| iRhythm Technologies, Inc. | United States | Zio ECG Utilization Software (ZEUS) System ZIO AT Patch | K081471 (2008) |
| BRAEMAR MANUFACTURING, LLC Present in Europe in other categories | United States | ECAT2 Generic | registered |
| COMMWELL RESEARCH & DEVELOPMENT LTD. | Israel | Commwell | registered |
| Cardiac Designs, LLC | United States | ECG Check | K170506 (2017) |
| Coala Life AB | Sweden | Coala Heart Monitor US Rx | K182040 (2019) |
| FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED | India | Frontier X Plus | registered |
| HeartBeam, Inc. | United States | HeartBeam ECG System | K250258 (2025) |
| LOHMAN TECHNOLOGIES, LLC | United States | AfibAlert / hom ecg+ | registered |
| NEUROSOFT, OOO | – | CloudEKG | registered |
| Otsuka Pharmaceutical Co., Ltd. | United States | MyCite Patch | registered |
| RHYTHMEDIX, LLC | United States | RhythmStar | K141813 (2014) |
| ADVANCED MONITORED CAREGIVING | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| Bernd Richter GmbH | Germany | – | registered |
| Bioserenity Sas Present in Europe in other categories | France | – | K173248 (2018) |
| Cardiomedix, Inc. | United States | – | K172801 (2017) |
| Carre Technologies, Inc. | Canada | – | K243981 (2025) |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Datrix | United States | – | registered |
| East West | United States | – | registered |
| Ecordum, Inc. | United States | – | K193296 (2020) |
| Emsere, Inc | Netherlands | – | registered |
| G-Medical Innovations , Ltd. | Israel | – | K173589 (2018) |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| Global Instrumentation, LLC | United States | – | registered |
| Health Watch, Inc. | Israel | – | K142476 (2015) |
| Huinno Co., Ltd. | South Korea | – | K243438 (2025) |
| Innokas Yhtyma Oy Present in Europe in other categories | Finland | – | registered |
| Kaynes Technology India Limited | India | – | registered |
| Kestra Medical | United States | – | registered |
| Kitron Technologies Inc. | United States | – | registered |
| Livmor | United States | – | K201208 (2020) |
| MILLSTONE MEDICAL OUTSOURCING LLC. | United States | – | registered |
| Maquet Critical Care AB Present in Europe in other categories | United States | – | registered |
| Masimo Corporation Present in Europe in other categories | United States | – | registered |
| Measure Labs, Inc. (Dba Preemptiveai, Inc.) | United States | – | K250233 (2026) |
| Mindray DS USA, Inc. | United States | – | registered |
| Nanowear, Inc. | United States | – | K212160 (2021) |
| Neurosoft, Inc. | United States | – | registered |
| NextPhase Medical Devices LLC | United States | – | registered |
| OMRON HEALTHCARE Co., Ltd. Matsusaka Factory | Japan | – | registered |
| ORTA MEDICAL LTD | Israel | – | registered |
| Purebrand Solutions LTD | United Kingdom | – | registered |
| RRDonnelley | United States | – | registered |
| Regent Electron Suzhou Co., Ltd | China | – | registered |
| Ryder Electronics (Shenzhen) Ltd. | China | – | registered |
| Screentec Oy | Finland | – | registered |
| Shandong Corecare Technology Limited | China | – | K222842 (2022) |
| Spacelabs Healthcare Present in Europe in other categories | United States | – | registered |
| Taiwan Scientific Corporation | Taiwan | – | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | – | registered |
| Twin River Group | United States | – | registered |
| Tz Medical, Inc. Present in Europe in other categories | United States | – | K001634 (2000) |
| Verily Life Sciences, LLC | United States | – | K213357 (2022) |
| VitalSigns Technology Co., Ltd. Present in Europe in other categories | Taiwan | – | K243003 (2025) |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
| YAHORNG DONGGUAN ELECTRONIC CO LTD | China | – | registered |
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