DAXAN expands wholesale ready-to-use catheter line for urology distributors

Chengdu Daxan Innovative Medical Tech Co., Ltd. is pitching its ready-to-use hydrophilic catheter portfolio and OEM/ODM services to urology distributors in regulated markets. The company says its portfolio, manufacturing scale and EU, U.S. and China regulatory clearances are designed to support multi-market supply programs.

Why it matters: - Urology distributors are shifting buying criteria from basic product availability to complete supply systems, including infection-control features, regulatory clearance and private-label flexibility. - Ready-to-use intermittent catheters can reduce preparation steps for clinicians and patients. - Closed-system and no-touch designs are gaining traction because they limit direct contact during insertion and can help lower catheter-associated urinary tract infection risk. - DAXAN is positioning itself as a single-source manufacturing partner for distributors building durable urology product lines across regulated markets.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd., which operates under the DAXAN brand, announced a wholesale ready-to-use hydrophilic catheter portfolio for urology distributors. - The company was founded in 2016 and says it has more than nine years of hydrophilic catheter manufacturing experience. - DAXAN operates a 6,000+ m² ISO 13485:2016-certified cleanroom facility in Chengdu, China. - Annual production capacity exceeds 20 million hydrophilic catheters. - DAXAN products are exported to more than 25 countries across Europe, North America, Asia-Pacific and the Middle East. - DAXAN invited distributors and importers to review product specifications, OEM service terms and regulatory documentation at the company’s website. - The company also listed its LinkedIn page at its social media profile.

The details: - DAXAN’s ready-to-use lineup includes the Duro-Pocket® closed system, the Pre-Lubricated Nelaton and the DuroFlex™ flexible-tip catheter. - The company also offers OEM/ODM private-label services across FR sizes CH06 through CH24. - The Duro-Pocket® Ready-to-Use variant arrives prehydrated and requires no additional lubrication or water activation. - The Duro-Pocket® catheter uses a fully enclosed no-touch introducer tip, fire-polished eyelets and a soft medical-grade TPU body. - The integrated urine collection bag holds up to 1,300 mL. - Duro-Pocket® sizes cover Pediatric 6–14FR, Female 8–18FR and Male 8–18FR. - Standard wholesale packaging is 30 units per box and 300 units per carton. - The Pre-Lubricated Nelaton catheter is made from DEHP-free and BPA-free medical-grade TPU with hot-polished side eyelets. - The Pre-Lubricated Nelaton line spans Pediatric Female and Male through Adult Female and Male sizes from 6–24FR. - The DuroFlex™ Pre-Lubricated Flexible Tip ISC Catheter is designed for male urethral anatomy. - DuroFlex™ uses a flexible ball-shaped tip, comes in 10–16FR sizes and a 40 cm length, and includes a non-touch gripper sleeve. - DuroFlex™ is packaged in individual sterile aluminum foil pouches with a dual tear-opening design. - DAXAN’s OEM/ODM program covers multiple tube lengths, four tip options — straight Nelaton, ball-tip, soft-tip and Tiemann/Coudé — and PVC or TPU tube material. - Private labeling, custom packaging artwork and outer carton specifications are included in the OEM program. - The company’s Coatapex™ Hydrolyx™ hydrophilic coating platform is based on polyvinylpyrrolidone chemistry. - DAXAN says the coating achieves a coefficient of friction as low as 0.02 and maintains stable superlubricity for more than 24 hours after activation. - The coating platform also includes antimicrobial, anti-encrustation and anti-thrombogenic surface properties. - DAXAN says the coating platform is supported by patents for activation-free super-lubricious coating technology, Patent No. ZL201811203221.3, and a water-based hydrophilic lubricious coating, Patent No. ZL201810063901.3. - DAXAN’s quality system is built on ISO 13485:2016 certification. - The company holds CE Marking under EU Medical Device Regulation 2017/745 through the Full Quality Assurance route. - Two FDA 510(k) clearances cover the U.S. market: K212567 for the hydrophilic intermittent catheter line and K243175 for the TPU intermittent catheter line. - DAXAN’s FDA Establishment Registration FEI 3023329815 is verifiable through the FDA 510(k) database. - China NMPA registration covers domestic market compliance. - Export documentation includes a Free Sale Certificate and a Certificate of Origin issued by CCPIT. - DAXAN’s production lines include extrusion, molding, punching and automated packaging.

Between the lines: - The announcement is aimed at distributors that want to consolidate sourcing across multiple regions instead of managing separate suppliers for each market. - The company is emphasizing compliance and coating technology as much as product variety, which suggests competition in this category is being driven by regulatory readiness and clinical differentiation. - DAXAN’s pitch also reflects a broader shift in urology procurement toward products that can support home care, institutional use and self-catheterization with less handling.

What's next: - DAXAN says distributors and importers can review specifications, OEM terms and regulatory documentation through its sales channels. - The company is likely to use its existing clearances, export footprint and private-label capabilities to pursue additional distributor agreements in regulated markets. - Further adoption will depend on buyer evaluation of product performance, documentation and market-specific registration needs.