China Customized ECG Electrode Patches Manufacturers Suppliers Factory - Wholesale Service

Product Overview

Our high-performance disposable ECG electrode patches are engineered for stable bio-potential signal acquisition across diagnostic, monitoring, and ambulatory healthcare settings. Built for global medical device brands, hospital groups, and healthcare distributors, our production lines deliver reliable low electrical impedance and consistent adhesion throughout wear cycles ranging from 24 hours to 7 days. We support comprehensive customization—including specialized backing materials, snap designs, and hydrogel formulations—tailored to meet precise clinical diagnostic requirements and international regulatory standards.

Disposable ECG Electrode Pads
Product Name: Disposable ECG Electrode Pads. Specifications: Customizable. These pads use medical-grade non-woven fabric or foam as the base material, coated with medical-grade pressure-sensitive

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Single-lead ECG Electrode Pads
Product Name: Single-Lead ECG Electrode Patch (Disposable Medical Grade). Our Single-Lead ECG Electrode Patch is a high-performance medical device designed for accurate cardiac signal acquisition in

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12-lead ECG Electrode Pads
Product Name: 12-Lead ECG Electrode Pads. We present our premium 12-Lead ECG Electrode, a high-performance medical-grade sensor designed for diagnostic electrocardiography and continuous cardiac

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3-lead ECG Electrode Pads
Premium 3-Lead ECG Electrode Pads – Manufacturing Excellence & Global Certifications. Our 3-lead ECG electrode pads are engineered for reliable cardiac monitoring, offering superior signal clarity

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Multi-lead ECG Electrode Pads
Product Name: Multi-Lead ECG Electrode Pads. Specifications: Customizable. These pads use medical-grade non-woven fabric or PU film as the substrate. A conductive silver paste layer is formed on the

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Silver Chloride Circuit Board
Product Name: Silver Chloride Circuit (Silver/Silver Chloride Sensing Electrode). Specifications: Customizable. This product uses medical-grade polymer substrates (such as PET, PP, or PE) as the

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Veterinary ECG Electrode Pads
Product Name: Animal ECG Electrode Pads. Specifications: Customizable. These products use medical-grade non-woven fabric, elastic fabric, or flexible fabric as the base material. They are equipped

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Construction & Materials

Backing Substrate:

Medical-grade polyethylene (PE) foam, breathable non-woven fabric, or waterproof polyurethane (PU) film optimized for short-term diagnostics or extended wear.

Conductive Interface:

High-purity Ag/AgCl (Silver/Silver Chloride) coated sensor element, ensuring stable electrochemical potential and minimal motion artifact interference.

Adhesive Layer:

Hypoallergenic, skin-friendly medical acrylic adhesive, providing secure skin fixation without residual transfer upon clean removal.

Conductive Medium:

High-viscosity wet liquid gel or solid hydrogel, ensuring rapid signal baseline stabilization and uniform skin contact impedance.

Connector Stud:

Corrosion-resistant stainless steel or carbon-filled ABS snap stud, fully compatible with standard 4.0mm snap-lead ECG cables.

Functional Performance Standards

AC Impedance: < 150 Ohm (significantly outperforming the ANSI/AAMI EC12 standard threshold of < 3 kOhm).

DC Offset Voltage: < 1 mV to minimize baseline drift during critical clinical tracings.

Internal Noise: < 150 uV, securing a high signal-to-noise ratio for precise arrhythmia detection.

Defibrillation Recovery: Potential returns to baseline within 1 second following high-voltage discharge.

Adhesion Stability: Maintains a secure skin bond under dynamic body movement and perspiratory conditions for up to 72 hours (standard) or 14 days (extended wear).

Technical Specifications Table

Parameter	Specification Standard	Test Method
Dimensions	Adult: 50mm x 50mm / Pediatric: 30mm x 35mm	Digital Caliper Measurement
Backing Thickness	0.8 mm to 1.2 mm (Material dependent)	Micrometer Gauge
Adhesive Peel Strength	> 5.0 N / 25 mm on stainless steel	ASTM D3330
Shelf Life	24 Months from date of manufacture	Accelerated Aging (ASTM F1980)
Sterilization Status	Non-sterile or ETO Sterile options	ISO 11135

Clinical Applications

Diagnostic 12-lead Resting ECG
Holter Monitoring and Ambulatory Telemetry
Cardiac Stress Testing (Treadmill / Ergometer)
ICU/CCU Continuous Patient Bedside Monitoring
Long-term Holter Patch Devices

Global Customization & OEM/ODM Services

We provide end-to-end contract manufacturing and private-label services backed by a robust global supply chain:

Dimension & Shape:

Custom die-cutting for round, teardrop, or rectangular designs matching proprietary device housings.

Formulation Customization:

Adjustable gel moisture content and adhesive tackiness tailored for neonatal, geriatric, or athletic skin profiles.

Private Labeling:

Custom pouch printing with REF numbers, lot codes, barcode serialization, and brand logos.

Packaging Options:

Bulk clinical packaging (50 pcs/bag) or individual peel-open blister packs configured for procedural kits.

Manufacturing & Quality Assurance

Cleanroom Production: Manufactured in ISO Class 7 (Class 10,000) controlled cleanrooms to completely eliminate particulate and biological contamination.

Automated Die-Cutting: CNC rotary die-cutting lines ensure strict dimensional tolerances within +/- 0.1 mm.

In-Line Inspection: Automated optical inspection (AOI) systems continuously monitor sensor coating uniformity and gel placement precision.

Laboratory Testing: In-house electrochemical testing facilities verify impedance, DC offset, and peel adhesion for every production lot prior to factory release.

Quality & Compliance

Quality Management System: ISO 13485:2016 certified medical device manufacturing facility.

Regulatory Compliance: Designed, manufactured, and tested in strict accordance with ANSI/AAMI EC12 (Disposable ECG Electrodes).

Biocompatibility Evaluation: Full toxicological and biological safety assessments conducted per ISO 10993 (Cytotoxicity, Sensitization, and Intracutaneous Reactivity).

Full Traceability: Complete lot traceability from raw polymer batches to final sterilized finished goods.

FAQ

Q: What is the difference between wet gel and solid hydrogel electrodes?

A: Wet liquid gel provides immediate, low-impedance electrical contact, making it ideal for short-term diagnostic resting ECGs and stress tests. Solid hydrogel features a cohesive matrix that retains moisture over extended wear periods, preventing skin maceration during 24-hour to 7-day Holter monitoring.

Q: How do you ensure batch-to-batch electrical consistency?

A: Every production batch undergoes automated electrochemical testing for AC impedance and DC offset using standardized multi-channel testing fixtures before packaging. Test reports are archived per lot for complete regulatory traceability.

Q: Are these electrode patches compatible with standard ECG lead wires?

A: Yes. The integrated snap studs comply with standard 4.0mm snap-connector specifications, ensuring secure mechanical and electrical compatibility with universal Holter and diagnostic cable sets.

Q: What is the standard lead time for OEM orders?

A: Standard production lead time for custom OEM orders ranges from 4 to 6 weeks following design and artwork approval, depending on packaging complexity and sterilization requirements.

Q: What biocompatibility certifications do the skin-contact materials hold?

A: All direct skin-contact materials—including the adhesive, backing, and gel—have passed complete biocompatibility testing in compliance with ISO 10993 standards for cytotoxicity, skin sensitization, and irritation.

Q: What is the Minimum Order Quantity (MOQ) for custom-printed pouches?

A: For custom-printed foil pouches with private branding, the standard MOQ starts at 50,000 units per specification, while unprinted standard bulk packaging supports lower initial trial quantities.

We're well-known as one of the leading ECG electrode patches manufacturers and suppliers in China. We warmly welcome you to wholesale high quality ECG electrode patches made in China here from our factory. If you have any enquiry about customized service, please feel free to email us.

Silver Chloride Circuit Board, 12 lead ECG Electrode Pads, Disposable ECG Electrode Pads