Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsElectrocardiographs
Advanced diagnosis electrocardiographs
EMDN code Z12050302
Manufacturers registered in Europe (EUDAMED) 8
- 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) 162
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 |
|---|---|---|---|
| Mortara Instrument, Inc. | United States | ELI 380 Patient Cable Lead Set ELI 150c ELI 280 Q-Stress XScribe | K152944 (2016) |
| LUTECH INDUSTRIES INC Present in Europe in other categories | United States | Lutech | registered |
| Edan Instruments, Inc. Present in Europe in other categories | China | Electrocardiograph Patient Monitor PC ECG ECG Cable Connection Cable SE-1202 Series Electrocardiograph | K252463 (2026) |
| 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 |
| Fukuda Denshi USA, Inc. Present in Europe in other categories | United States | FUKUDA DENSHI | K173226 (2018) |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | patient lead wire Leads Cardiac Workstation Spirometry Sensor | K241556 (2024) |
| Jaeger Medical GmbH Present in Europe in other categories | Germany | Jaeger Vyaire | registered |
| Schiller AG Present in Europe in other categories | Switzerland | Diagnostic Station DS20 CARDIOVIT® AT-102 CARDIOVIT® FT-1 CARDIOVIT® AT-2 plus CARDIOVIT® AT-101 CARDIOVIT® FT-1 | K183425 (2020) |
| ATHENA GTX, INC. | United States | WVSM Pro, Wireless Vital Signs Monitor Professional | 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 |
| Avante | – | True ECG 12 Velocity Pro True ECG Plus True ECG Advance True ECG 12T Velocity EKG | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | MAC CAM CARESCAPE ONE | K251670 (2026) |
| 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 | K243305 (2025) |
| Philips Medical Systems Hsg | – | Philips PageWriter | registered |
| ANYBATTERY, INC | United States | Anybattery | K160667 (2017) |
| Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Present in Europe in other categories | China | Digital Electrocardiograph | K160092 (2016) |
| 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 |
| eResearchTechnology GmbH Present in Europe in other categories | Germany | SpiroSphere MasterScope MasterScope ECG | registered |
| Bionet Co., Ltd. Present in Europe in other categories | South Korea | Cardio Q50, Cardio Q70 CardioCare2000 Cardio P1 CardioXP CardioTouch3000 Cardio7 | K231160 (2023) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | K171360 (2018) |
| 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 |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare | 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 |
| Shenzhen Carewell Electronics Co., Ltd. | China | Carewell | K200036 (2020) |
| Shenzhen Comen Medical Instruments Co., Ltd. Present in Europe in other categories | China | Comen | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED ELECTROCARDIOGRAPH | K111805 (2011) |
| Shenzhen Viatom Technology Co., Ltd. Present in Europe in other categories | China | Wellue/Viatom BP2 Blood Pressure Monitor LEPU MEDICAL Checkme Wellue | registered |
| Medical Predictive Science Corp. | United States | HeRO duet HeRO ES HeRO solo HeRO symphony | K180242 (2018) |
| WITHINGS Present in Europe in other categories | France | Withings® | K252474 (2025) |
| Guangdong Biolight Meditech Co., Ltd. Present in Europe in other categories | China | Digital Electrocardigraph Digital Electrocardiograph | K131858 (2014) |
| 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 |
| COMMWELL RESEARCH & DEVELOPMENT LTD. | Israel | Commwell | registered |
| Cardiocomm Solutions, Inc. | Canada | HeartCheck BT PEN Handheld ECG HeartCheck Palm | K122632 (2014) |
| HHS SYSTEMS, INC. | United States | HindexRV | K142551 (2015) |
| 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 |
| Medeia, Inc. Present in Europe in other categories | United States | VitalScan HRV VitalScan ANS | registered |
| PHILIPS FRANCE Present in Europe in other categories | Finland | Cardiologs Platform | registered |
| Philips Ds North America LLC Present in Europe in other categories | United States | CAB,ECG,5 LD,UNSHLD,10FT,SAFTY MR Patient Care Single Patch ECG Electrodes (25) | registered |
| 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) |
| BIOFOURMIS SINGAPORE PTE. LTD. | Singapore | RhythmAnalytics | registered |
| CARDIOLOGS TECHNOLOGIES | France | Cardiologs Platform | K212112 (2021) |
| Caf Medical Solutions, Inc. | United States | LIFEE | K220362 (2022) |
| Cardiac Insight, Inc. | United States | Cardea 20/20 ECG | registered |
| EMAY (HK) LIMITED | – | Emay | registered |
| FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED | India | Frontier X Plus | registered |
| HOPKINS UNIFORM COMPANY | – | Hopkins Medical Products® | registered |
| HeartBeam, Inc. | United States | HeartBeam ECG System | registered |
| IMEDRIX INC. | – | KARDIOSCREEN | registered |
| Inmedix, Inc. | United States | CloudHRV™ System | K241217 (2025) |
| NASIFF ASSOCIATES INC | – | CardioCard | registered |
| NUVOMED, INC. | – | NuvoMed | registered |
| Omron Healthcare, Inc. Present in Europe in other categories | United States | Complete Blood Pressure Monitor +EKG | K060766 (2006) |
| Physiq, Inc. | United States | physIQ Heart Rhythm and Respiration Module | K193415 (2020) |
| SAFEBEAT RX INC. | United States | SafeBeat Rx App | registered |
| Shl Telemedicine International , Ltd. Present in Europe in other categories | Israel | CARDIO MONITOR CENTER VISION | K003392 (2001) |
| Sinpro Electronics Co., Ltd. | – | SINPRO | registered |
| Stethoai LLC | – | DaliaSense | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | ARROW | registered |
| VISIOMED GROUP | France | BEWELL CONNECT MyECG | registered |
| ZOLL MANUFACTURING CORPORATION Present in Europe in other categories | United States | ZOLL ECG Analysis Software | K182093 (2019) |
| AD Supply Group Limited | United Kingdom | – | registered |
| Accurkardia, Inc. | United States | – | K252361 (2025) |
| Acme Portable Machines, Inc. | United States | – | K152135 (2016) |
| Aidar Health, Inc | United States | – | registered |
| Amcg Co., Ltd. | South Korea | – | K232823 (2024) |
| Amphenol Alden Products Company | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| Applied Cardiac Systems | United States | – | K860249 (1986) |
| B-Secur Limited | United Kingdom | – | K200884 (2020) |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Beijing Choice Electronic Technololgy Co., Ltd. | China | – | K112622 (2012) |
| Bernd Richter GmbH | Germany | – | registered |
| Biocare Bio-Medical Equipment Co., Ltd. | China | – | K171517 (2018) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| Cardiacsense Present in Europe in other categories | Israel | – | K232445 (2024) |
| Cardio-Phoenix, Inc. Present in Europe in other categories | Canada | – | K182790 (2018) |
| Cirtec Medical Corporation | United States | – | registered |
| Coala Life AB | Sweden | – | K212163 (2022) |
| Creavo Medical Technologies, Ltd. | United Kingdom | – | K170154 (2017) |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Dailycare Biomedical, Inc. | Taiwan | – | K172778 (2018) |
| Dictum Health, Inc. | United States | – | registered |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | – | registered |
| Dreamtech co., ltd. | South Korea | – | registered |
| EDAN Diagnostics, Inc. | United States | – | registered |
| Ekgenius, LLC | United States | – | K232974 (2023) |
The 100 most active manufacturers are shown, out of 162.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- General purpose electrocardiographs70 manufacturers
- Electrocardiographs - hardware accessories38 manufacturers
- Electrocardiographs - medical device software32 manufacturers
- Electrocardiographs - consumables12 manufacturers
- Electrocardiographs - software accessories6 manufacturers
- Parent category : Electrocardiographs77 manufacturers