DAXAN expands urology catheter sourcing pitch to global distributors

Chengdu Daxan Innovative Medical Tech Co., Ltd. says it is offering distributors a single-source urology catheter supply model from its ISO 13485:2016-certified facility in Chengdu, China. The company is promoting multi-market regulatory clearances, OEM/ODM customization and export reach to more than 25 countries as it targets private-label and regional import partners.

Why it matters: - DAXAN is positioning itself as a one-stop supplier for distributors that want to consolidate urology catheter sourcing, quality documentation and private-label production. - The company says the model can reduce the need to qualify multiple manufacturers across different regulatory markets. - The offer is aimed at importers launching or expanding urology lines in Europe, the U.S. and China.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd. announced its urology catheter manufacturing and OEM/ODM capabilities for distributors. - The company is based in Chengdu, Sichuan, China. - DAXAN says it produces five categories of urology devices from a 6,000 m² ISO 13485:2016-certified cleanroom. - DAXAN says annual output exceeds 20 million units. - DAXAN says exports reach more than 25 countries.

The details: - The intermittent catheter line includes nine SKUs across major tip types and patient groups. - The line includes Nelaton straight-tip catheters, Tiemann angled-tip catheters, DuroFlex™ flexible ball-tip ISC catheters, a compact folding catheter and the Duro-Pocket® closed-system line. - Pediatric and adult sizes run from 6 FR to 24 FR across female and male configurations. - The broader portfolio includes two Foley catheter variants, two DJ ureteral stents, two ureteral access sheath configurations and one urology guidewire line. - DAXAN says all five categories are manufactured and quality-controlled in the same certified facility. - The company says intermittent catheters, DJ stents, sheaths and guidewires share a unified regulatory documentation trail. - Foley catheters follow a separate certification pathway. - DAXAN lists three R&D patents covering anti-reflux autonomous urination, drug-loaded catheter technology and a non-balloon indwelling catheter. - The company says those patent references do not replace product-specific CE MDR or FDA 510(k) clearance. - DAXAN says its manufacturing chain covers extrusion, molding, punching and packaging in one controlled environment. - The company says its proprietary Coatapex™ Hydrolyx™ hydrophilic coating is made in-house for the intermittent catheter line. - DAXAN says the coating is based on a polyvinylpyrrolidone formulation, reaches a coefficient of friction as low as 0.02 and maintains stable lubricity for more than 24 hours after activation. - The company says no latex, DEHP or BPA is present in any product line. - DAXAN says its EU clearance is under CE Marking through the Full Quality Assurance pathway of EU MDR 2017/745 for the hydrophilic intermittent catheter line. - The company says its U.S. clearances are FDA 510(k) decisions K212567 for hydrophilic intermittent catheters and K243175 for TPU intermittent catheters. - DAXAN says its FDA Establishment Registration number is FEI 3023329815. - DAXAN says China NMPA registration covers the domestic market. - The company says a Free Sale Certificate and a Certificate of Origin from CCPIT support export activity. - The OEM/ODM program covers private-label intermittent catheter launches for distributors, importers and brand owners. - FR sizes in the custom program run from CH06 to CH24. - Tip options include Nelaton straight, Tiemann angled, flexible ball tip and the enclosed introducer tip used in the Duro-Pocket® line. - Tube materials include PVC and medical-grade TPU. - DAXAN says the TPU formulation is DEHP-free, BPA-free, eco-friendly and biodegradable under natural conditions. - Private labeling and custom packaging are available across all SKUs. - Standard packaging is 30 units per box and 300 units per carton, with distributor-specific configurations available. - DAXAN says its OEM orders are made in the same ISO 13485:2016 cleanroom that produces its branded range.

Between the lines: - The announcement is as much about supplier qualification as product range. - DAXAN is trying to sell compliance, manufacturing control and documentation continuity as a procurement advantage. - The multiple clearances and export references are meant to reduce friction for distributors working across different markets. - The company is also signaling depth beyond manufacturing through clinical education content and trade show participation.

What's next: - DAXAN is inviting distributors to request samples, OEM customization quotes and regulatory documentation through the company’s website. - The company says it will continue engaging international distributors through major industry trade fairs. - DAXAN is likely to keep marketing its OEM/ODM program as a private-label platform for regional launch partners.

The bottom line: - DAXAN is pitching itself as a single-source urology catheter manufacturer for distributors that want certified production, multi-market regulatory support and private-label flexibility from one supplier.