Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instruments
Electrocardiographs
EMDN code Z120503
Manufacturers registered in Europe (EUDAMED) 77
- 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) 276
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 |
|---|---|---|---|
| LifeSync Corporation | United States | AMC Lifesync | K071751 (2007) |
| Fogg System Company, Inc. Present in Europe in other categories | United States | FOGG SYSTEM COMPANY, INC. | K222712 (2023) |
| CURBELL MEDICAL PRODUCTS, INC. | United States | SURE-LOCK 3-LD ECG CABLE, MOLDED, SNAP, A 3-LD DIN ECG CABLE, A 5-LD ECG CABLE, MOLDED, SNAP, A 5-LD TWIN ECG CABLE, A 5-LD DIN ECG CABLE, A | K182220 (2018) |
| Mortara Instrument, Inc. | United States | ELI 380 Patient Cable Lead Set ELI 150c ELI 280 Q-Stress XScribe | K152944 (2016) |
| Maguire Enterprises, Inc. | – | MAGUIRE Cable CV200101 | registered |
| GRAPHIC CONTROLS ACQUISITION CORP | – | Vermed St Jude Medical Bard Physio Control Biosense | registered |
| OWENS & MINOR DISTRIBUTION, INC. | – | Medichoice | registered |
| RPI | – | PATIENT CABLE - 3 LEAD DN SKIN TEMP PROBE (REUSABLE) PATIENT CABLE - 10 LD FX BN SKIN TEMP PROBE - 10 PATIENT CABLE - 3 LEAD DU PATIENT CABLE-5 LEAD DU | registered |
| LUTECH INDUSTRIES INC Present in Europe in other categories | United States | Lutech | registered |
| APK Technology Co.,Ltd. Present in Europe in other categories | China | APK Nihon Kohden Mindray Philips | K170536 (2017) |
| MERIT CABLES INCORPORATED | United States | Patient Leadwire Patient Cable Patient Lead Wire Set Patient Lead Wire Patient Leadwire Set Patient Leadwire Set of 5 | K942321 (1994) |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | registered |
| Fysicon B.V. Present in Europe in other categories | Netherlands | QMAPP | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | K181726 (2018) |
| Philips Medical Systems Hsg | – | Philips PageWriter NOUN Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets ECG Electrodes MX40 Masimo Leadsets and Adapters | registered |
| ZOLL Medical Corporation Present in Europe in other categories | United States | PROPAQ M R SERIES | registered |
| Eko Devices, Inc. | United States | CORE 500 Digital Stethoscope - Sapphire Chestpiece CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue CORE 500 Digital Stethoscope - Navy Blue Bundle CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy CORE 500 Digital Stethoscope - Champagne Bundle CORE 500 Digital Stethoscope - Champagne Earpiece | registered |
| STRYKER SUSTAINABILITY SOLUTIONS, INC. | United States | Medtronic | registered |
| Rising Eagle Medical LLC | – | 9Line MEDALink | registered |
| SENSORONICS INCORPORATED | – | Sensoronics | 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 | K203556 (2021) |
| Nissha Medical Technologies Present in Europe in other categories | United States | INTEGRAL PROCESS Cables & Leadwires Boston Scientific Vermed | registered |
| Authentic Medical | United States | SureLead | K181089 (2020) |
| Physio-Control Corp. Present in Europe in other categories | United States | ASSY, CABLE, ECG, 3 WIRE, IEC, 8 FT ASSY, CABLE, ECG, 4 WIRE, IEC, 5 FT ASSY, CABLE, ECG, 4 WIRE, AHA, 5 FT ASSY, CABLE, ECG, 3 WIRE, AHA, 8 FT ASSY, CABLE, ECG, 15LEAD, 6 WIRE PRECORD | K240156 (2024) |
| Avante | – | True ECG 12 Velocity Pro True ECG Plus True ECG Advance True ECG 12T Velocity EKG | registered |
| Remington Medical, Inc. | United States | Safety Adapter Remington Medical, Inc Disposable Extension Cable | K971968 (1997) |
| Boston Scientific Corp Present in Europe in other categories | United States | RHYTHMIA HDx™ Cable, SureLink™ Cable, Easy-Mate™ Electrode Cable Rhythmia™ Mapping System | K172591 (2017) |
| Ivy Biomedical Systems, Inc. Present in Europe in other categories | United States | ECG Lead Wires ECG Patient Cable ECG Trunk Cable ECG Snap Lead Wires | K240087 (2024) |
| Orantech Inc. Present in Europe in other categories | China | Orantech SpO2 Adapter Cable One Piece ECG Monitor Cable ECG Monitor Trunk Cable ECG Leadwires Invasive BP Adapter Cable | K182327 (2019) |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| PROTEUS DIGITAL HEALTH, INC. | – | Proteus Digital Health Feedback System | registered |
| MED-DYNE, INC. | United States | Med-Dyne | K080112 (2008) |
| Shenzhen Caremed Medical Technology Co., Ltd. Present in Europe in other categories | China | Caremed | K153188 (2016) |
| ATHENA GTX, INC. | United States | WVSM Pro, Wireless Vital Signs Monitor Professional | registered |
| 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 |
| A & E MEDICAL CORPORATION | – | Fastlock | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Tz Medical, Inc. Present in Europe in other categories | United States | Cable, V1-MPC to Electrode – Phillips (P2) (Grey/Flat) (~10ft) Cable, V1-MPC to Defibrillator/Pacemaker – Phillips (Grey/Flat) (~10ft) Cable, Bifurcated, Return for RF to ESU Connector Stockert 70 (EPT) (~10ft) Cable, Return for RF Banana Plug Connector (Radionics/(Atakr) (~10ft) Cable, V1-MPC to Electrode – Medtronic/QuickCombo (~10ft) Cable, V1-MPC to Defibrillator/Pacemaker – Zoll (~10ft) | K062577 (2006) |
| Kego Corporation | Canada | KING KING Snap Lead/DIN Connector KING Dual Snap Lead/DIN Connector | registered |
| Nihon Kohden America, Inc. Present in Europe in other categories | United States | cardiofax S cardiofax M | K072217 (2007) |
| Masimo Corporation Present in Europe in other categories | United States | Masimo W1 Radius VSM Rainbow | K243305 (2025) |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED ELECTROCARDIOGRAPH ADVANCED PATIENT MONITOR | K111805 (2011) |
| 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) |
| ANYBATTERY, INC | United States | Anybattery | K160667 (2017) |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare Trulink Lifecard | registered |
| AFFINITY MEDICAL TECHNOLOGIES, LLC | United States | Affinity Cable and Leadwire System EMG Cable for Nerveäna | K980806 (1998) |
| Baylis Medical Technologies, Inc. Present in Europe in other categories | Canada | PowerWire Pro Radiofrequency Guidewire Kit PowerWire 14 Radiofrequency Guidewire Kit RFP-100A Connector Cable | K254114 (2026) |
| eResearchTechnology GmbH Present in Europe in other categories | Germany | SpiroSphere MasterScope MasterScope ECG | registered |
| Lifewatch | – | LifeWatch Mobile Cardiac Telemetry 3-Lead LifeWatch Mobile Cardiac Telemetry 1 Lead Patch MicroER Explorer | registered |
| WITHINGS Present in Europe in other categories | France | Withings® | K252474 (2025) |
| Beijing Choice Electronic Technology Co., Ltd. Present in Europe in other categories | China | ChoiceMMed | registered |
| ECHONOUS, INC. Present in Europe in other categories | United States | Kosmos Bridge Kosmos Bridge - Refurbished Kosmos Accessories - US Kosmos Accessories - US - Refurbished Kosmos ECG Patient Cable - International Kosmos Accessories - International | registered |
| Samsung Electronics Co., Ltd. Present in Europe in other categories | South Korea | ECG Monitor App Samsung ECG App v 1.3 (ECG) Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | K240909 (2024) |
| Shenzhen Changke Connect Electronics Co., Ltd. Present in Europe in other categories | China | Changke Connect | K200026 (2020) |
| Bittium Biosignals Oy Present in Europe in other categories | Finland | Faros Bittium Faros 180 waterproof Faros 360 waterproof Bittium Faros | registered |
| Corscience GmbH & Co. KG Present in Europe in other categories | Germany | COR12 GoECG | K183369 (2018) |
| MEDIBLU MEDICAL LLC | United States | Mediblu | K233266 (2024) |
| Midmark Corp. Present in Europe in other categories | United States | Midmark IQecg® Digital ECG Disposable EZ-Trode ECG Electrodes IQstress Prep Kits | registered |
| SCOTTCARE CORPORATION, THE | United States | EZLink-R OneView EZLink EZLink-C Transtelephonic Receiving Module EventCare | K895719 (1990) |
| ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | – | SJM™ | registered |
| Shenzhen Carewell Electronics Co., Ltd. | China | Carewell | K200036 (2020) |
| Baylis Médicale Cie Inc | – | BMC Connector Cable RFP-100A Connector Cable | registered |
| Shanghai Draeger Medical Instrument Co.,Ltd. | China | IBP transducer adapter cable ECG trunk cable 12-lead SinglePin Vista300 Adapter cable Masimo/ Nellcor SpO2 Vista 300 Temp adapter Jack Vista 300 | K251669 (2025) |
| Shenzhen Coreray Technology Co., Ltd Present in Europe in other categories | China | coreray ECG cable coreray ECG cable Patient Monitoring Cable (SpO2 Extension Cable) coreray EKG cable | K192404 (2020) |
| Shl Telemedicine International , Ltd. Present in Europe in other categories | Israel | CARDIO MONITOR CENTER VISION smartheart CardioSen'C RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | K113514 (2012) |
| St Jude Medical | United States | SJM™ | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | Multi-Link™ | K211294 (2021) |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Cadwell Patch Electrode with Snap Connector | registered |
| Cardiocomm Solutions, Inc. | Canada | HeartCheck BT PEN Handheld ECG HeartCheck Palm GEMS Mobile ECG HeartCheck CardiBeat | K181310 (2019) |
| Medical Predictive Science Corp. | United States | HeRO duet HeRO ES HeRO solo HeRO symphony | K180242 (2018) |
| Qompium NV | Belgium | FibriCheck | K173872 (2018) |
| COMMWELL RESEARCH & DEVELOPMENT LTD. | Israel | Commwell | registered |
| Medicalgorithmics S.A. Present in Europe in other categories | Poland | DeepRhythmAI DeepRhythm Platform | K232161 (2024) |
| Prolaio, Inc. | United States | prolaio Heart Rhythm and Respiration Module prolaio Heart Rhythm Module | registered |
| SPAULDING MEDICAL, LLC | United States | Spaulding Electrocardiograph | registered |
| VECTRACOR INC | United States | Office Medic Universal SmartECG VectraplexECG System | K173952 (2018) |
| VENNI INSTRUMENTS INC. | – | Venni / Biolight | registered |
| Vitalograph , Ltd. Present in Europe in other categories | United States | ECG | registered |
| Atrility Medical LLC | United States | AtriAmp AtriAmp - Pacing Cable | K200674 (2020) |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| Beijing Rongrui-Century Scie.&Tech. Co,. Ltd. | China | R-RUI | registered |
| Biotricity | United States | BIOFLUX | K172311 (2017) |
| Cortex, Inc. Present in Europe in other categories | – | OptiMap™ Cable Kit - NA OptiMap™ ECG Cables - NA | registered |
| FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED | India | Frontier X Plus | registered |
| HHS SYSTEMS, INC. | United States | HindexRV | K142551 (2015) |
| HeartBeam, Inc. | United States | HeartBeam ECG System | K250258 (2025) |
| Lifesignals, Inc. Present in Europe in other categories | United States | UbiqVue Holter UbiqVue | registered |
| MDOLORIS MEDICAL SYSTEMS Present in Europe in other categories | France | HFVi monitor BA-HFVI-V1 | K142969 (2016) |
| MESI d.o.o. | Slovenia | MESI mTABLET ECG MESI mTABLET ECG Extension, BANANA AHA | registered |
| Piccolo Medical, Inc. | – | Piccolo Medical | registered |
| VIVAQUANT, INC. | United States | Rhythm Express | K183704 (2019) |
| VIVE HEALTH LLC Present in Europe in other categories | United States | Vive Precision VIVE | registered |
| Vales & Hills Biomedical Tech. , Ltd. | China | ECG Acquisition Systems | K163607 (2017) |
| Volcano Corporation | United States | CORE M2 Vascular System CORE FM SYSTEM | K190078 (2019) |
| iRhythm Technologies, Inc. | United States | Zio ECG Utilization Software (ZEUS) System ZIO AT Patch | K081471 (2008) |
| BIOFOURMIS SINGAPORE PTE. LTD. | Singapore | RhythmAnalytics | registered |
| BRAEMAR MANUFACTURING, LLC Present in Europe in other categories | United States | ECAT2 Generic | registered |
| CARDIOLOGS TECHNOLOGIES | France | Cardiologs Platform | K212112 (2021) |
| Caf Medical Solutions, Inc. | United States | LIFEE | K220362 (2022) |
| Cardiac Designs, LLC | United States | ECG Check | K170506 (2017) |
The 100 most active manufacturers are shown, out of 276.
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