CHENGDU DAXAN INNOVATIVE MEDICAL TECH CO., LTD.
Advanced Urology Care Solutions & OEM Partner
End-to-End Manufacturing: From R&D to precision production under ISO 13485 standards.
Professional manufacturer of hydrophilic catheters.
Exported to over 25 countries globally.
Over 6,000 square meters of clean workshops & testing centers.
Capacity exceeds 20 million hydrophilic catheters per year.
Advanced extrusion, molding, punching, and packaging tech.
Navigating the Complexities of Medical Device Commercialization
Bringing a Class II medical device, such as a hydrophilic intermittent catheter, to the global market is an intricate endeavor fraught with technical, clinical, and regulatory hurdles. Medical device companies frequently encounter severe bottlenecks when attempting to align innovative product development with stringent, ever-evolving international regulatory frameworks. The transition from a promising prototype to a commercially viable, compliant product requires more than just manufacturing capabilities; it demands a holistic, integrated pipeline.
At Chengdu Daxan Innovative Medical Tech Co., Ltd., we have redefined the OEM paradigm. We do not merely act as a contract manufacturer; we function as a comprehensive strategic partner. Our philosophy is simple yet powerful: One Partner, Full Pipeline. We bridge the critical gap between high-precision engineering and complex regulatory submissions. By embedding regulatory readiness into the very DNA of our product development cycle, we empower our clients to bypass common pitfalls, significantly reduce time-to-market, and confidently launch their urology care solutions in highly regulated jurisdictions worldwide.
Whether you are a rising med-tech startup seeking a reliable production backbone or an established multinational corporation looking to diversify your urology portfolio, Daxan’s robust infrastructure—anchored by our ISO 13485 certified quality management system—ensures that every catheter produced meets the pinnacle of safety, efficacy, and clinical performance.
Our OEM Impact Metrics
Built-In Regulatory Readiness: CE MDR & FDA 510(k) Mastery
The most significant barrier to entry in the medical device sector is not manufacturing, but compliance. Daxan’s OEM service is engineered with Built-In Regulatory Readiness. We generate, compile, and maintain the exhaustive documentation required by Notified Bodies and the FDA concurrently with the manufacturing process, ensuring you enter new markets without bureaucratic delays.
FDA 510(k) Pathway Optimization
Navigating the FDA 510(k) premarket notification process for urological catheters requires meticulous demonstration of substantial equivalence. Daxan provides comprehensive technical support, including detailed device descriptions, predicate device comparison matrices, and rigorous performance testing data. We supply the requisite mechanical testing (tensile strength, flow rate, balloon reliability) and chemical characterization data, ensuring your submission package is robust, transparent, and primed for rapid FDA clearance. Our engineering team anticipates reviewer questions, preemptively addressing them within the provided data sets.
CE Mark & MDR Transition
The transition from the Medical Device Directive (MDD) to the stringent Medical Device Regulation (MDR) in Europe has intensified the demand for clinical evidence and post-market surveillance. Daxan’s OEM framework is fully aligned with MDR requirements. We construct exhaustive Technical Files, incorporating detailed Risk Management Reports (ISO 14971), Clinical Evaluation Reports (CERs), and comprehensive labeling protocols. By partnering with Daxan, European distributors and global brands can confidently affix the CE mark, knowing the underlying technical documentation can withstand the most rigorous Notified Body audits.
ISO 10993 Biocompatibility
Hydrophilic catheters come into direct contact with the delicate urethral mucosa. Therefore, uncompromised biocompatibility is non-negotiable. Daxan conducts and documents extensive biocompatibility testing in strict accordance with the ISO 10993 series. Our documentation packages include verified results for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity. Furthermore, our advanced hydrophilic coating formulations are meticulously analyzed to ensure zero particulate shedding and absolute chemical stability, safeguarding patient health and fulfilling essential regulatory prerequisites globally.
Advanced Manufacturing: From Raw Polymer to Packaged Device
Our capacity exceeding 20 million hydrophilic catheters per year is not merely a number; it is a testament to our highly automated, AI-monitored, and technologically advanced manufacturing ecosystem housed within our 6,000 square meter cleanroom facility.
1. Precision Polymer Extrusion
The foundation of a superior catheter lies in its tubing. Utilizing state-of-the-art extrusion technology, Daxan processes medical-grade PVC, TPU, and Silicone with microscopic precision. Our automated extrusion lines maintain strict dimensional tolerances for both outer and inner diameters, ensuring optimal flexibility, kink resistance, and patient comfort. Real-time laser micrometers continuously monitor the extrusion profile, instantly rejecting any anomalies to maintain a flawless production baseline.
2. Atraumatic Eyelet Punching & Molding
To prevent urethral trauma during insertion and withdrawal, the catheter eyelets must be impeccably smooth. Daxan employs advanced thermal molding and precision punching technologies to create perfectly rounded, polished, and burr-free drainage eyes. Our proprietary forming process ensures that the structural integrity of the catheter tip is maintained, providing a seamless transition that significantly enhances the user experience and minimizes the risk of micro-abrasions.
3. Proprietary Hydrophilic Coating
The core of our technological prowess resides in our hydrophilic coating application. We utilize advanced UV-curing and thermal-bonding techniques to covalently bind the hydrophilic polymer to the catheter substrate. This results in a highly lubricious, friction-free surface upon hydration. Our coating dramatically reduces the coefficient of friction, ensuring a painless catheterization process. The coating's durability is rigorously tested to ensure it remains intact throughout the entire procedure, leaving no residue within the urinary tract.
4. Automated Packaging & Sterilization
Operating within our ISO Class 8 clean workshops, the final assembly and packaging are heavily automated to eliminate human error and contamination risks. We offer versatile packaging solutions, including aluminum foil pouches and medical-grade blister packs, customized to include water sachets or pre-lubricated formats. Following packaging, the products undergo validated sterilization processes (Ethylene Oxide or Gamma irradiation), with comprehensive sterility assurance documentation provided for your regulatory dossiers.
Quality Control Driven by AI & ISO 13485
In the realm of medical device manufacturing, quality is not a final inspection step; it is an ongoing, integrated process. Daxan operates strictly under the ISO 13485:2016 Quality Management System. However, we push beyond standard compliance by integrating smart technologies and AI-assisted visual inspection systems into our production lines.
Our high-speed optical sorting machines utilize machine learning algorithms to detect microscopic defects in the catheter tubing, coating uniformity, and eyelet smoothness. This technological integration ensures that every single unit among the 20 million produced annually meets exact specifications.
By choosing Daxan as your OEM partner, you are not just sourcing a product; you are acquiring a technologically advanced manufacturing arm. We provide full traceability for every batch, comprehensive Certificate of Analysis (CoA) reports, and detailed Device History Records (DHR), granting you complete visibility and control over your supply chain.
Smart Inspection
Automated optical systems scan 360° of the catheter surface for absolute perfection.
ISO 13485
Internationally recognized QMS ensuring consistent, safe, and effective medical devices.
Full Traceability
End-to-end tracking from raw material sourcing to final sterilized packaging.
Technical Files
Ready-to-submit dossiers tailored for Notified Bodies and Regulatory Agencies.
Enter New Markets with Absolute Confidence
Expanding your urology product line internationally shouldn't be stalled by manufacturing constraints or regulatory red tape. Daxan's "One Partner, Full Pipeline" approach is specifically designed to mitigate risk, optimize capital expenditure, and accelerate your commercial success.
Cost Efficiency
Eliminate the need for massive capital investment in cleanrooms, extrusion machinery, and specialized coating equipment. Leverage Daxan's established infrastructure and economies of scale to achieve highly competitive unit costs without compromising on premium quality.
Speed to Market
Our integrated R&D, manufacturing, and regulatory teams work in parallel, not in silos. This synchronized workflow drastically cuts down the lead time from initial concept to commercial launch, allowing you to capture market share faster than your competitors.
Brand Protection
Your brand reputation is paramount. By utilizing our rigorously tested, highly lubricious hydrophilic catheters backed by comprehensive clinical and technical documentation, you ensure that healthcare professionals and patients experience the utmost reliability and comfort.