SJ Medical
SJ Medical
Pioneering Vascular Interventional Medical Devices Since 2015 — Trusted by Healthcare Providers Across Europe, Asia, the Middle East & Africa.
🌐 CE Certified · ISO 13485 · CFDA Approved · Global DistributorA decade of innovation in vascular interventional solutions — built on science, driven by clinical need.
Hangzhou SJ Medical Co., Ltd. was established in 2015 and is dedicated to the research, development, manufacturing, and commercialization of vascular interventional medical devices. 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.
GMP-compliant manufacturing infrastructure designed for precision, consistency, and world-class quality control.
Our manufacturing plant spans approximately 5,000 square meters, purpose-built to accommodate high-volume production of complex vascular interventional devices with full workflow separation.
The facility features a million-class clean workshop with localized hundred-class areas for critical assembly processes, ensuring contamination-free production environments at every stage.
Our team includes senior engineers and specialists with decades of hands-on experience in the medical device industry, providing deep technical leadership across R&D, production, and QC functions.
Four pillars that set us apart in the global vascular interventional device market.
Continuous investment in research and development, backed by multiple patents, ensures our products remain at the clinical frontier of vascular intervention technology.
End-to-end quality management from raw material sourcing to finished product inspection, fully aligned with ISO 13485 and CE regulatory frameworks.
CE, ISO 13485, and CFDA certifications demonstrate our ability to meet diverse international market requirements and regulatory standards across multiple regions.
From pre-sales technical consultation to responsive after-sales service, we provide a seamless, professional experience for every partner and distributor worldwide.
A complete portfolio of vascular interventional devices engineered for precision, safety, and optimal clinical outcomes.
Designed for coronary artery interventions, our balloon catheters deliver precise dilation with excellent trackability and pushability, supporting physicians in achieving consistent procedural success.
Engineered for peripheral vascular applications including iliac, femoral, and below-the-knee procedures, providing reliable performance across a broad range of vessel anatomies.
Our stent systems are developed with precision engineering to provide durable scaffolding, optimal radial strength, and biocompatibility for long-term vascular patency.
Comprehensive access solutions including introducers and sheaths that facilitate safe and efficient vascular entry for a wide range of minimally invasive procedures.
High-performance diagnostic catheters designed for precise angiographic imaging and hemodynamic measurement, supporting accurate clinical decision-making in catheterization labs.
Complementary therapeutic devices that integrate seamlessly with our core product lines to provide complete, end-to-end solutions for complex vascular intervention cases.
Our devices are clinically validated for a broad spectrum of minimally invasive vascular procedures.
Our coronary products are applied in the diagnosis and treatment of coronary artery disease (CAD), supporting angioplasty and stenting procedures that restore blood flow to the heart muscle.
Peripheral intervention products address arterial and venous diseases in the lower limbs, renal, and mesenteric vessels, improving procedural efficiency and patient quality of life.
Diagnostic devices support accurate visualization and assessment of vascular anatomy, enabling physicians to plan and execute interventions with greater confidence and safety.
Our regulatory achievements reflect an unwavering commitment to product safety, quality, and international market access.
Full CE marking for European market access, confirming conformity with EU Medical Device Regulation (MDR) requirements for safety and performance.
Certified Quality Management System for medical device design and manufacturing, ensuring consistent process control and continuous improvement across all operations.
National Medical Products Administration (NMPA/CFDA) registration for domestic market authorization, demonstrating full compliance with Chinese regulatory standards.
Official free sale certificates facilitating international distribution and market entry across multiple regulatory jurisdictions in Asia, the Middle East, and Africa.
State-of-the-art manufacturing and inspection technologies that guarantee precision, repeatability, and full-process quality assurance.
| Equipment / Technology | Application | Capability Level |
|---|---|---|
| ⚙️ Precision Balloon Forming Equipment | Balloon catheter manufacturing — controlled inflation geometry and wall thickness uniformity | High Precision |
| 🔦 Laser Welding Technology | Micro-scale catheter component bonding with minimal heat-affected zones | Medical Grade |
| 🏷️ Laser Marking Systems | Permanent, high-resolution product identification and traceability marking | Regulatory Compliant |
| 🧫 Laboratory Testing Facilities | Comprehensive mechanical, biocompatibility, and performance validation testing | Full-Process QC |
| 🔬 Cleanroom Inspection Systems | In-process and final product inspection under controlled contamination-free conditions | GMP Standard |
SJ Medical products are trusted by healthcare institutions across four continents.
SJ Medical has established long-term partnerships with clients across Europe, Asia, the Middle East, and Africa. Through consistent product quality, regulatory compliance, and dedicated customer service, the company has built a reputation as a reliable vascular device supplier in international markets.
The company continues to actively expand its global distribution network, seeking qualified partners and distributors to bring its innovative vascular interventional solutions to more healthcare providers and patients worldwide.
Flexible manufacturing partnerships — from custom product development to private-label production at scale.
Our R&D team collaborates closely with OEM partners to develop customized vascular device specifications aligned with specific clinical and market requirements.
Full private-label manufacturing capability, including custom packaging, labeling, and IFU documentation prepared to meet target market regulatory requirements.
We offer flexible minimum order quantities to accommodate both emerging distributors and large-scale procurement programs, with proven capacity for rapid scale-up.
Our regulatory affairs team provides comprehensive technical documentation support for CE, ISO, and local market registration filings on behalf of OEM partners.
Real-world partnerships that demonstrate SJ Medical's clinical impact and global reach.
Europe · Cardiology
A leading European cardiovascular device distributor partnered with SJ Medical to supply CE-certified coronary balloon catheters to hospital catheterization labs in Italy and Spain. The partnership has sustained multi-year volume contracts with consistent product quality and on-time delivery performance.
CE Certified Coronary Intervention Long-Term SupplyAsia · Peripheral Vascular
SJ Medical supplied peripheral balloon catheters and access systems to a hospital network in Indonesia, supporting the expansion of a minimally invasive peripheral vascular intervention program. Technical training and clinical support were provided to local medical teams.
Peripheral Vascular Clinical Training Access SystemsMiddle East & Africa · OEM
A regional medical device brand in Turkey and Egypt engaged SJ Medical for a full OEM private-label program, including custom packaging design, local-language IFU preparation, and regulatory filing support for both markets.
OEM / Private Label Regulatory Support Multi-CountryTrusted by distributors, hospitals, and healthcare professionals across four continents.
SJ Medical's coronary balloon catheters have demonstrated outstanding clinical performance in our catheterization labs. The product quality is highly consistent, and their technical support team responds promptly to any queries. A reliable long-term supplier.
We have been working with SJ Medical for over three years. Their peripheral vascular products meet our clinical standards, and the OEM service they provide has allowed us to build a strong local brand with full regulatory compliance in our market.
The GMP-certified cleanroom manufacturing and rigorous QC processes give us full confidence in SJ Medical's products. Their ISO 13485 certification and CE documentation package significantly simplified our import registration process in our country.
SJ Medical is committed to providing comprehensive and professional services throughout the entire customer journey.
Expert technical consultation to help partners identify the right products and configurations for their specific clinical and market requirements.
Dedicated technical support from our experienced engineering team, providing product training, clinical guidance, and troubleshooting assistance.
Streamlined order management and logistics coordination ensuring accurate, timely delivery to customers across global distribution channels.
Responsive after-sales service including complaint handling, product feedback management, and continuous improvement initiatives based on customer input.
Join our growing global network of distributors and healthcare partners. Discover how SJ Medical's vascular interventional devices can elevate your clinical offerings.
Contact Us for Partnership Inquiry