Instruments for functional explorations and therapeutic interventions
Cardiology and cardiosurgery instruments
EMDN code Z1205
Manufacturers registered in Europe (EUDAMED) 166
- 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) 456
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) |
| St Jude Medical | United States | EnSite™ MediGuide™ WorkMate Claris™ EnSite Precision™ PressureWire™ SJM™ | 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) |
| 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 |
| Terumo Cardiovascular Systems Corporation | United States | Terumo® Advanced Perfusion System 1 Sarns™ Modular Perfusion System 8000 CDI™ Blood Parameter Monitoring System 550 Sarns™ Cardioplegia Set Sarns™ Infusion Line CAPIOX® Holders | K221895 (2023) |
| 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) |
| NOVOSCI CORP. | United States | GOODWIN HEART LINE METHODIST CARDIOPLEGIC ADMIN. SET GOODWIN LUNG LINE EXTENSION LINE W/16 GA MODIFIED NEEDLE LIFEGIFT CARDIOPLEGIC ADMIN SET CARDIOPLEGIA ADMINISTRATION SET | registered |
| Conmed Corporation Present in Europe in other categories | United States | CONMED | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline Medline Industries, Inc. | K181726 (2018) |
| Philips Medical Systems Hsg | – | Philips PageWriter IECG Stress NOUN Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets | 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 |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| IRVINE BIOMEDICAL, INC. | – | Therapy™ SJM™ Cool Point™ Safire™ TX Safire™ Duo MediGuide Enabled™ | P040014 (2026) |
| STRYKER SUSTAINABILITY SOLUTIONS, INC. | United States | Medtronic | registered |
| Rising Eagle Medical LLC | – | 9Line MEDALink | registered |
| SENSORONICS INCORPORATED | – | Sensoronics | registered |
| Global Instrumentation, LLC | United States | Matrix Wearable Patient Cable Matrix Holter System GI Holter System WA Holter System Pouch | K202456 (2020) |
| 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) |
| Avante | – | True ECG 12 Velocity Pro True ECG Plus True ECG Advance True ECG 12T Velocity EKG | registered |
| 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) |
| ZURICH MEDICAL INC. | United States | Zurich Medical Accessory Cable Zurich Pressure Guidewire System | K190852 (2019) |
| 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) |
| Remington Medical, Inc. | United States | Safety Adapter Remington Medical, Inc Disposable Extension Cable | K971968 (1997) |
| ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | – | SJM™ Safire™ Livewire™ Livewire TC™ | registered |
| Datrix | United States | VX3+ Sirona AMI CardioLabs Datrix Cardiostaff | K031074 (2003) |
| 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) |
| Sorin Group Italia S.R.L. Present in Europe in other categories | United States | DATA MASTER Inspire Exchanger Sinergy and Mini Bag CPB DAC Cardiotomy BMR 1900 UTILITY BRACKET | K250150 (2025) |
| 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) |
| Thoratec Laboratories Corp. | United States | CentriMag™ CIRCULAR OXYGENATOR BRACKET LARGE CIRCULAR OXYGENATOR BRACKET SMALL METAL LOCKING FEATURE FOR CENTRIMAG MOTOR SQUARE OXYGENATOR BRACKET CMAG TRANSPORTER, SPARE PART KIT | registered |
| 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 |
| 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) |
| North East Monitoring, Inc. | United States | Holter Analysis Software DR200 DR181 DR300 DR400 Gateway | K142424 (2014) |
| ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | – | TA1019 CRITIFLO(TM) TAK1572T CRITIFLO(TM) TAK1760M CRITIFLO(TM) TAK1536T PRESSURE MONITORING DOME SET P23XL™ | registered |
| Midmark Corp. Present in Europe in other categories | United States | Midmark IQecg® Digital ECG Disposable EZ-Trode ECG Electrodes IQstress Prep Kits Midmark IQholter® Digital Holter Recorder Midmark IQholter EX Digital Holter Prep Kit - Midmark IQholter, 5-lead | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED ELECTROCARDIOGRAPH ADVANCED PATIENT MONITOR | K111805 (2011) |
| Icentia Inc. | Canada | CardioSTAT EART | K223049 (2023) |
| 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) |
| 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) |
| SCOTTCARE CORPORATION, THE | United States | HolterCare Editing Kit HolterCare Novi Software EZLink-R OneView EZLink | K083382 (2009) |
| TERUMO CORPORATION Present in Europe in other categories | United States | CAPIOX | registered |
| Centerline Biomedical, Inc. | United States | IOPS Viewpoint IOPS™ IOPS® IOPS Visionary System IOPS Mobile Cart IOPS™ Software Application | K263016 (2026) |
| ANYBATTERY, INC | United States | Anybattery | K160667 (2017) |
| Lifewatch | – | Lifestar AF Express King of Hearts AF LifeWatch Mobile Cardiac Telemetry 3-Lead LifeWatch Mobile Cardiac Telemetry 1 Lead Patch MicroER Explorer | registered |
| Sibel Health Inc. Present in Europe in other categories | United States | ANNE Bedside Wireless Charger Sibel Spacelabs Trek Chest Patch 7-Day ANNE Chest Adhesive Shelf Box ANNE Chest Sensor Kit Sibel Spacelabs Trek Chest Patch Adhesive Sibel Spacelabs Trek Charger | 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) |
| Cardiocomm Solutions, Inc. | Canada | HeartCheck BT PEN Handheld ECG HeartCheck Palm GEMS Win Arrhythmia GEMS Win Air GEMS Win HL7 GEMS Win TTM & ICD | K181310 (2019) |
| 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) |
| eResearchTechnology GmbH Present in Europe in other categories | Germany | SpiroSphere MasterScope MasterScope ECG | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | TruWave, VAMP Plus TruWave | registered |
| Lifesignals, Inc. Present in Europe in other categories | United States | UbiqVue Holter UbiqVue LifeSignals | registered |
| Med Michigan Holdings, LLC | United States | Surge Cardiovascular Eight Medical | registered |
| 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) |
| MEDIBLU MEDICAL LLC | United States | Mediblu | K233266 (2024) |
| Mennen Medical, Inc. | United States | EMS-XL Horizon XVu | K091165 (2009) |
| 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 |
| Cardiac Insight, Inc. | United States | Cardea 20/20 ECG Cardea SOLO | K162503 (2017) |
| Cortex, Inc. Present in Europe in other categories | – | OptiMap™ System - NA OptiMap Cart OptiMap Monitor OptiMap™ Workstation OptiMap Amplifer OptiMap™ Cable Kit - NA | 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 |
| Fischer Medical | United States | Bloom2 Bloom | K173439 (2018) |
| Kardium Inc | Canada | Globe Positioning System (GPS™) Cable Globe® Controller Globe® Workstation Globe Positioning System (GPS™) Electrodes Globe® Catheter Globe® PF Generator | P240044 (2026) |
| 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) |
| Vektor Medical, Inc. | United States | vMap Control Unit vMap Disposables Vektor Medical vMap Software | K252429 (2025) |
| Vitalograph , Ltd. Present in Europe in other categories | United States | VitaloJAK ECG | K253293 (2025) |
| iRhythm Technologies, Inc. | United States | Zio ECG Utilization Software (ZEUS) System ZIO AT Patch ZIO XT Patch Zio monitor | K252859 (2026) |
| Corscience GmbH & Co. KG Present in Europe in other categories | Germany | COR12 GoECG | K183369 (2018) |
| MICROPACE PTY LIMITED Present in Europe in other categories | Australia | MICROPACE PTY LIMITED Micropace ORLAB StimLab | K253088 (2026) |
| Shenzhen Carewell Electronics Co., Ltd. | China | Carewell | K200036 (2020) |
| Baylis Médicale Cie Inc | – | BMC Connector Cable RFP-100A Connector Cable | registered |
| COROVENTIS Research AB Present in Europe in other categories | Sweden | CoroFlow Upgrade kit CoroFlow CoroFlow Cardiovascular System CoroFlow PPG Software CoroFlow TouchPad | K252238 (2025) |
| ENDOPHYS HOLDINGS, LLC | United States | Endophys Pressure Sensing Sheath Kit - 8F 25 CM Endophys Pressure Sensing Sheath Kit - 6F 12 CM Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No Guidewire Endophys Pressure Sensing Sheath Kit - 8F 11 CM | registered |
| NOVAMED-USA INC. | United States | NOVATEMP | registered |
| SMART SOLUTIONS TECHNOLOGIES SL | Spain | Nuubo System | K231620 (2023) |
| 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) |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | Multi-Link™ | K211294 (2021) |
| Biotricity | United States | BIOFLUX Biotricity Biotres Pro | K222017 (2022) |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Cadwell Patch Electrode with Snap Connector | registered |
The 100 most active manufacturers are shown, out of 456.
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