A Leading Manufacturer for Fluid Management System
Shijiazhuang Yuanding Medical Device Co., Ltd., established in 2015, is a wholly-owned subsidiary of Xinle Medical Group, specializing in the R&D, production, and sales of disposable medical consumables in fluid management system, catheter and drainage system.
Driven by innovation, the company has been recognized with authoritative designations including National High-Tech Enterprise and Hebei Provincial Specialized and Sophisticated SME, holding over 60 invention and utility model patents. Yuanding Medical operates a comprehensive R&D platform with large-scale, high-standard, automated production capabilities. Our products are certified to ISO 13485, FDA, and CE international standards.
Currently, Yuanding Medical serves customers in more than 40 countries and regions worldwide, covering over 500 Class A Tertiary hospitals and more than 2,000 Class A Secondary hospitals in China, and maintains long-term partnerships with multiple listed companies and industry leaders. Our products are widely used in operating rooms, ICUs, emergency departments, respiratory units, anesthesia departments, and general wards.
Guided by customer needs and a clear strategic vision, Yuanding Medical continuously optimizes its products and services, committed to providing safe, reliable, high-quality medical consumables and integrated solutions to healthcare institutions worldwide.
High-Standard Automated Production
Our production workshop and cleanroom facilities ensure precision, consistency and quality at scale.
Automated Production Workshop
Our large-scale production workshop integrates high-speed automated assembly lines, delivering consistent output across every product family while minimizing manual handling.
- High-speed automated assembly and packaging lines
- In-line vision inspection and pressure testing
- Scalable capacity for OEM and high-volume orders
- End-to-end traceability across every batch
Class-Compliant Cleanroom
Sterile products are manufactured within class 100,000 cleanrooms with controlled temperature, humidity and particulate levels, ensuring aseptic integrity for sterile single-use device.
- Class-compliant environments for sterile manufacturing
- Controlled temperature, humidity and air filtration
- Validated cleaning and sterilization processes
- Continuous environmental monitoring and control
Safety, Quality & Sustainability
Product Safety
Every product is manufactured under strict quality management systems and validated to ISO 13485, FDA and CE standards, ensuring safety for patients and clinicians at every stage of care.
- Sterile, single-use design eliminates cross-contamination risk
- Biocompatible, latex-free materials for safe patient contact
- Leak-free, pressure-tested closures for reliable performance
Quality Control
Comprehensive in-process and final inspection, supported by automated production and full traceability, guarantees consistent quality from batch to batch.
| Stage | Control |
|---|---|
| Incoming material | 100% batch verification |
| In-process | Automated vision + pressure testing |
| Final inspection | AQL sampling per ISO 2859 |
| Traceability | Full batch-level tracking |
Internationally Recognized Quality
Our products and quality systems are certified to internationally recognized standards, giving partners confidence in every shipment.
- ISO 13485 Quality Management
- FDA Registration
- CE Marking
- National High-Tech Enterprise
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Trusted Partner to Global Healthcare Systems
Shijiazhuang Yuanding Medical Device Co., Ltd. works closely with leading domestic tertiary hospitals, international medical distributors, and specialized medical organizations.