Our 3-lead ECG electrode pads are engineered for reliable cardiac monitoring, offering superior signal clarity and patient comfort. Designed for diagnostic and continuous monitoring applications, these electrodes combine advanced materials with precision manufacturing to meet the rigorous demands of hospitals, clinics, and home healthcare.
Production Details:
Each electrode is produced in an ISO Class 8 cleanroom environment to ensure contamination-free assembly. The manufacturing process begins with high-purity silver/silver chloride (Ag/AgCl) sensors, screen-printed onto a flexible polyester backing to guarantee stable half-cell potential and low offset. A medical-grade conductive adhesive hydrogel is then coated uniformly, ensuring strong skin adherence while minimizing irritation. The foam backing provides cushioning and breathability, reducing motion artifacts. Automated die-cutting and sealing machines maintain consistent shape and gel thickness, followed by rigorous electrical testing for impedance, offset voltage, and defibrillation recovery. Finally, electrodes are packaged in moisture-proof foil pouches to preserve gel conductivity and sterility (optionally EO sterilized).
Factory Advantages:
- State-of-the-Art Production: Fully automated lines with real-time monitoring ensure high output and batch-to-batch consistency.
- Vertical Integration: In-house R&D and tooling allow rapid prototyping and custom designs (cable assemblies, custom gels, or backing materials).
- Experienced Team: Over 15 years in medical electrode manufacturing, supporting global brands with OEM/ODM services.
- Capacity & Lead Time: Monthly output exceeds 10 million pieces, with flexible scheduling to meet urgent orders.
Certifications & Compliance:
ISO 13485:2016 – Certified quality management system for medical devices.
CE (MDR) – Full compliance with European Medical Device Regulation (EU 2017/745).
FDA 510(k) Cleared – Registered with U.S. FDA for marketing in the United States.
RoHS & REACH – All materials are phthalate-free and environmentally compliant.
Product Standards – Meet AAMI EC12, IEC 60601-2-27, and ISO 10993 biocompatibility requirements (cytotoxicity, sensitization, irritation).
With a commitment to quality and innovation, our 3-lead ECG electrode pads deliver the performance and safety that medical professionals trust. Contact us for partnership or sample requests.
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