XINKANG MEDICAL INSTRUMENT CO.,LTD.

Professional Customization, Global Trust – Your Strategic Partner for Medical Equipment OEM/ODM

Strong Manufacturing Capabilities
We have an 8,000-square-meter self-owned production base equipped with imported injection molding machines and automated production lines. Certified by ISO13485 quality management system, our products meet international standards such as CE and FDA.

Extensive Customization Experience
Over 20 years of professional experience, providing customization services to more than 50 well-known medical brands worldwide. We have over 200 successful cases, covering the customization of consumables for a full range of products, including multi-parameter monitors, 12-lead ECG machines, and respiratory anesthesia consumables.

Comprehensive Service Support

Flexible Cooperation: Supporting various cooperation models such as OEM branding, ODM customization, and modular customization.

Professional Team: A 30-person R&D team provides full-process services from concept design to mass production.

Rapid Response: Dedicated project managers provide one-on-one service, shortening new product development cycles by 30%.

Quality Assurance: A comprehensive traceability system ensures a product defect rate below 0.1%.

Successful Case Studies
Products customized for a well-known European brand have been exported to more than 30 countries due to their outstanding performance, gaining high recognition from the client.

Choosing us is not just choosing a supplier, but choosing a trustworthy long-term partner. Let's work together to contribute to the global healthcare industry!

Intelligent Manufacturing, Leading the Future – A Comprehensive Analysis of a Modern Production System
Advanced Production Equipment Matrix
Building an intelligent manufacturing base equipped with:
Precision injection molding, automated injection molding machines, robotic arms, automatic dispensing machines, and automatic thread trimming machines Etc.

Building a Four-Tier Quality Assurance System:
Incoming Material Inspection: Utilizing multiple measuring and inspection instruments, the raw material qualification rate is 99.95%.
Process Control: Establishing 28 quality control points to monitor key process parameters in real time.
Finished Product Testing: Simulating a clinical environment for 72-hour aging tests, with a failure rate of <0.1%.
Outgoing Shipment Review: Retaining samples of each batch of products and establishing a complete quality traceability file.
Superior Production Efficiency:
Rapid Response: Flexible production lines support product changeover within 15 minutes.
Capacity Guarantee: Daily output of consumables exceeds 3000 units.
On-Time Delivery: Precise production scheduling through the ERP system ensures a 98.5% on-time order delivery rate.
Continuous Improvement: Implementing lean production methods, resulting in an average annual efficiency increase of 12%.
Our production system has passed ISO13485 quality management system certification. Every step adheres to the "zero-defect" manufacturing philosophy, ensuring that every piece of equipment delivered meets medical-grade reliability standards.

Innovation Engine, Technological Leadership – Professional R&D Center for Medical Equipment and Consumables

Strong R&D Capabilities: A professional R&D team of 30 people, 60% of whom hold master's degrees or above and have an average of over 10 years of industry experience. The company has two major R&D centers in Shenzhen and Huizhou, and has established industry-university-research cooperation mechanisms with several universities in Shenzhen. Annual R&D investment accounts for 15% of the company's revenue.

Advanced R&D Platform: A comprehensive R&D system has been built:

Software Development: Self-developed embedded systems have passed IEC62304 medical software certification.

Mechanical Design: Utilizing the UG/NX 3D design platform for simulation analysis and early structural optimization.

Clinical Validation: Collaborating with top hospitals to conduct clinical trials to ensure the clinical applicability of products.

Abundant Innovation Achievements: In the past three years, we have obtained:

10 invention patents, 20 utility model patents, 25 software copyrights, and 30 design patents.

We adhere to a clinically oriented approach, launching 3-5 innovative products annually, leveraging our technological strength to create value for the global healthcare industry.

Professional Team, Comprehensive Support – Your Medical Device Service Experts

Our service team comprises senior engineers and technical experts in the medical device field, with an average of over 8 years of industry experience. All team members have undergone rigorous professional training, hold relevant technical certifications, and are able to provide multilingual technical support services to clients worldwide.

Inheriting Craftsmanship, Moving Forward with Innovation – Our Development Journey

2001：Expanding International Vision:

Leveraging Hong Kong's international platform to directly connect with global medical equipment market demands.
Trade Facilitation: Utilizing Hong Kong's free port advantages to establish efficient import and export trade channels.
Quality Certification Breakthrough: Adapting to international standards through the Hong Kong platform, laying the foundation for subsequent CE and FDA certifications.
Service Network Development: Initial establishment of a sales and service network covering Southeast Asia and the Middle East.

2008: Foundation Laying the Foundation
Founded in Shenzhen, the company focuses on the R&D and production of Compatible Spo2 sensor and Ecg cable . The first independently developed multi-parameter patient monitor was successfully launched, quickly gaining recognition in the domestic market thanks to its accurate monitoring performance and stable product quality.

2012: Product Expansion
Building on mature patient monitor technology, the company strategically expanded into the electrocardiograph ECG machine field. It introduced German precision manufacturing technology, established automated production lines, and achieved internationally advanced product precision. In the same year, it obtained EU CE certification and began entering the European market.

2015: Global Expansion
Established an international business division, focusing on developing the Southeast Asian, Middle Eastern, and Latin American markets. Established its first overseas technical support center to provide localized services to global customers. Products obtained US FDA certification, successfully entering the North American market.

2018: Completed Industry Chain
Completed the strategic layout of its respiratory anesthesia consumables product line, achieving full industry chain coverage from medical equipment to supporting consumables, ensuring that consumable products meet medical-grade standards.

2021 Smart Manufacturing:

We introduced Industry 4.0 intelligent production lines, achieving digital management of the production process， tens of millions of sets of consumables. We were recognized as a National High-tech Enterprise.

2023 Service Upgrade:

We established a global cloud service platform, enabling remote equipment monitoring and preventative maintenance. Our service network covers more than 120 countries and regions worldwide, making us a strategic supplier to many internationally renowned medical institutions.

2024 Standard Upgrade ：

Against the backdrop of continuously evolving global medical regulatory standards, we have taken the lead in completing comprehensive EU MDR (Medical Device Regulation) certification, marking another significant breakthrough following our strategic move to Hong Kong in 2001. The new certification covers our full range of products, including patient monitors, electrocardiographs, and respiratory and anesthesia consumables, signifying that our quality management system meets the latest EU regulatory requirements.

Certification Value:
Technological Leadership: Product safety and effectiveness gain authoritative EU recognition.
Market Access Advantage: Establishing higher compliance barriers and a competitive advantage in the EU market.
Quality System Upgrade: Promoting stricter traceability management across the entire supply chain.
Patient Safety Assurance: Establishing a comprehensive risk management system to ensure safe clinical use.

This certification not only solidifies our position in the EU market but also reflects our core philosophy of "patient safety at the center." Facing an increasingly stringent global regulatory environment, we consistently adapt and respond proactively to ensure our products continuously meet the highest international standards.

2025: Solid Foundation

After sever years of steady development, we have completed a strategic infrastructure investment—the acquisition and commissioning of a brand-new, self-owned production base. This modern factory, built to international standards, is not only the physical foundation of our company's development but also a tangible testament to our long-term commitment.

Significance of the Upgrade:

Capacity Guarantee: The building area has tripled, increasing annual production capacity by over 50%.

Quality Control: Fully independent production environment control ensures quality control throughout the entire process from raw materials to finished products.

Technology Upgrade: The introduction of intelligent manufacturing production lines enables digital management of the production process.

Cost Optimization: Overcoming the limitations of leased factory space, enabling long-term stable production planning.

The commissioning of the new factory marks the company's strategic transformation from "high-speed development" to "high-quality development." We are not only expanding production scale but also building a manufacturing base capable of continuous innovation and worthy of long-term customer trust. This factory will carry our original aspirations for the medical field, continuing to provide global customers with more reliable and advanced medical equipment solutions.

For these years, we have adhered to the development philosophy of "quality first, innovation-driven," evolving from single products to a full range of solutions, from the domestic market to a global footprint. Every step reflects our passion and dedication to the medical field.

Professional Medical Equipment and Accessories, Safeguarding Global Health Lifelines！

As a professional medical equipment manufacturer, we are committed to providing global healthcare institutions with high-quality integrated solutions for patient monitors, electrocardiographs, and respiratory anesthesia consumables. With a rigorous quality control system and international certification standards, our products serve more than 120 countries and regions worldwide, becoming a trusted partner for healthcare professionals.

Core Service Advantages:

End-to-End Quality Control: From raw material procurement to finished product delivery, we strictly implement the ISO13485 quality management system.

Global Service Network: We have established a localized technical support and after-sales service system covering five continents.

Customized Solutions: We provide personalized solutions for equipment configuration and consumable supply based on hospital level and clinical needs.

Rapid Response Mechanism: 72-hour emergency order processing ensures uninterrupted operation of medical equipment.

We deeply understand that medical equipment is related to life and health; therefore, we always adhere to technological innovation as the driving force and clinical needs as the guide, providing reliable, accurate, and durable medical equipment and consumables support to the global healthcare industry.