China Top Below-the-Knee Intervention Factories & Factory

Company Profile: SJ Medical Excellence

Hangzhou SJ Medical Co., Ltd. was established in 2015 and is dedicated to the research, development, manufacturing, and commercialization of vascular interventional medical devices. As one of the China Top Below-the-Knee Intervention Factories, the company focuses on both cardiovascular and peripheral intervention fields, striving to provide safe, reliable, and innovative solutions for healthcare providers worldwide.

Over the years, SJ Medical has developed a comprehensive product portfolio covering key areas of vascular intervention. Its offerings span from various types of balloon catheters for coronary and peripheral applications to supporting access and diagnostic devices, as well as advanced stent systems. Through continuous innovation and strong R&D capabilities, the company has obtained multiple patents and international certifications, laying a solid foundation for sustainable growth in both domestic and global markets.

The Global Landscape of Below-the-Knee (BTK) Intervention

The field of below-the-knee (BTK) intervention is currently witnessing unprecedented growth. As Peripheral Artery Disease (PAD) becomes increasingly prevalent, often linked to the global rise in diabetes and aging demographics, the demand for sophisticated endovascular therapies has surged. Medical institutions worldwide are moving away from traditional open surgeries toward minimally invasive techniques, which offer faster recovery times and better patient outcomes.

However, the BTK space is technically demanding. Vessels below the knee are often smaller, more calcified, and prone to complex lesions. This requires specialized equipment—such as ultra-low-profile balloon catheters and advanced stents—that provide both steerability and deliverability. As a result, hospitals and distributors are actively seeking top-tier manufacturers capable of meeting these strict clinical requirements.

Why Choose China’s Manufacturing Ecosystem?

Chinese factories like SJ Medical have evolved significantly, transitioning from simple component producers to high-tech, end-to-end medical device innovators. Global procurement managers now favor Chinese manufacturers for several compelling reasons:

• Vertical Integration: From raw material processing (like high-grade Ni-Ti alloys) to final sterilization, integrated workflows ensure superior quality control.
• Regulatory Compliance: Leading Chinese manufacturers strictly adhere to ISO 13485, CE, and CFDA standards, ensuring products meet the stringent regulatory hurdles of the EU and other international markets.
• Cost-Efficiency without Compromise: Advanced automated production lines reduce manual errors and overhead, allowing for competitive pricing that supports cost-sensitive healthcare systems globally.
• Scalability: With modern facilities like SJ Medical’s 5,000 sqm cleanroom environment, we have the capacity to handle large-scale orders while maintaining the flexibility for custom OEM/ODM development.

Our Factory & Quality Assurance

SJ Medical operates a modern manufacturing facility built in accordance with GMP standards. Our cleanroom environment is the heart of our operations, featuring a million-class clean workshop with localized hundred-class areas for critical assembly processes. This environment is essential for producing sterile, high-precision devices like catheter sheaths and angioplasty balloons.

Our technical team comprises industry veterans with decades of experience. Under the leadership of senior engineers, we maintain rigorous quality control protocols at every stage, from raw material procurement to final product testing. Our testing facilities include advanced balloon burst pressure testers, fatigue testers, and optical inspection systems, ensuring that every unit shipped is ready for critical clinical use.