Single-lead ECG Electrode Pads

Our Single-Lead ECG Electrode Patch is a high-performance medical device designed for accurate cardiac signal acquisition in clinical monitoring, Holter applications, and telemedicine settings. This single-use, non-invasive electrode conducts electrical signals generated by the patient's heart from the skin surface to an electrocardiograph monitoring device via standard ECG lead wires . The patch serves as a critical interface between patient and diagnostic equipment, ensuring reliable R-wave detection and stable baseline performance throughout the monitoring period.

The electrode features a precision-engineered multi-layer construction comprising a medical-grade non-woven fabric or foam backing, Ag/AgCl sintered sensor element, conductive hydrogel layer, and protective release liner. The production process utilizes advanced MEMS-inspired fabrication techniques where biocompatible substrates are layered with conductive materials through controlled deposition processes . The Ag/AgCl sensor element is manufactured via precision screen-printing or electroplating methods, ensuring consistent electrical performance with offset voltage below 1mV and impedance characteristics optimized for clinical accuracy. The hypoallergenic conductive hydrogel formulation provides stable signal transmission while maintaining gentle skin adhesion, with peel strength carefully calibrated between 1.0-2.0 N/cm for secure attachment without traumatic removal. Each patch undergoes 100% automated electrical testing for impedance, offset voltage, and defibrillation overload recovery. Standard dimensions approximate 99mm × 99mm, compatible with universal snap or tab connectors for major monitoring platforms . Manufacturing occurs in ISO Class 7 (Class 10,000) cleanrooms with strict environmental controls for temperature (18-28°C) and humidity (40-65% RH) during hydrogel lamination and packaging .

As a specialized OEM/ODM manufacturer with vertically integrated operations, we maintain strict quality control across the entire supply chain from raw material sourcing to finished product sterilization. Our facility operates under ISO 13485:2016 certified quality management systems with annual surveillance audits ensuring continuous compliance . We have invested in fully automated production lines featuring rotary die-cutting, precision hydrogel dispensing, and vision inspection systems, achieving production capacities exceeding 50 million units annually. Our technical team specializes in custom formulations for specific applications including long-term monitoring, pediatric populations, and challenging patient populations requiring extended wear times. With over 15 years of contract manufacturing experience, we serve major medical device brands requiring private labeling, custom packaging configurations, and regulatory support for global market access.

Our Single-Lead ECG Electrode Patches are manufactured in full compliance with international regulatory standards:

• ISO 13485:2016: Full certification for medical device quality management systems with scope covering design, development, and manufacture of ECG electrodes and related accessories
• FDA Registration: Facility and product dossiers registered with U.S. Food and Drug Administration; Device listed under Product Code DRX (Electrode, Electrocardiograph)
• CE Marking (MDR): Certified under European Medical Device Regulation (EU) 2017/745 for Class I medical devices
• ISO 10993 Biocompatibility: Comprehensive testing passed for cytotoxicity, skin sensitization, and irritation (ISO 10993-5, -10, -23)
• AAMI EC12 Compliance: Meets American National Standard for disposable ECG electrodes including offset voltage, AC impedance, and defibrillation overload recovery requirements
• REACH & RoHS Compliant: Manufacturing processes free from hazardous substances including phthalates and heavy metals
• NMPA Certification: Valid Medical Device Production License for China market access
• Storage Stability: Validated shelf life of 24-36 months under controlled storage conditions (10-32°C, 5-80% relative humidity)

Our Single-Lead ECG Electrode Patches represent the convergence of precision engineering and medical-grade material science, delivering the signal integrity and patient comfort required for contemporary cardiac diagnostics.