DAXAN launches DuroFlex catheter with male-anatomy tip and OEM support

Chengdu Daxan Innovative Medical Tech says its DuroFlex pre-lubricated flexible tip intermittent self-catheter is designed for male urethral anatomy and backed by triple-market regulatory coverage. The company is pitching the product to distributors and procurement teams seeking coating data, ISO-certified manufacturing and private-label customization.

Why it matters: - Male intermittent self-catheterization can create friction and insertion challenges because of urethral curvature. - DAXAN is targeting distributors and procurement teams that now evaluate catheter manufacturers on engineering, coating performance, regulatory documentation and OEM scope, not product appearance alone. - The company is positioning DuroFlex as a sourceable option for multi-market use in Europe, North America and China.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd. introduced DuroFlex, a pre-lubricated flexible tip intermittent self-catheter for men. - The catheter uses a flexible ball-shaped tip and DAXAN’s Coatapex Hydrolyx super-hydrophilic coating technology. - DAXAN says the product is supported by Patent No. ZL201610861058.4 and is available with OEM customization across a broad range of French sizes. - The company is based in Chengdu, Sichuan, China.

The details: - DuroFlex comes in 10FR, 12FR, 14FR and 16FR sizes. - Each catheter has a 40 cm length. - Each unit is sterile, single-use and sealed in an individual aluminum foil pouch. - Packaging includes 30 units per box, dual tear holes and an adhesive hanging sticker. - A non-touch gripper sleeve supports aseptic handling. - Hot-polished smooth eyelets are designed to reduce urethral irritation during insertion and withdrawal. - The catheter body uses medical-grade TPU. - The material is DEHP-free, BPA-free and free of natural latex rubber. - The TPU formulation is described as biodegradable in natural environments. - DAXAN says the product is manufactured in a 6,000+ m² ISO 13485:2016-certified cleanroom facility. - The facility includes extrusion, molding, punching, packaging and an in-house testing center. - Annual output exceeds 20 million hydrophilic-coated catheters. - DAXAN also says its coating output is supported by a patented automated coating device and process, Patent No. ZL201610859829.6. - The company says DuroFlex holds CE marking under EU MDR 2017/745, FDA 510(k) clearances K212567 and K243175, and China NMPA registration. - The FDA Establishment Registration number is FEI 3023329815. - Export documents include a Free Sale Certificate and a Certificate of Origin issued by CCPIT. - DAXAN was founded in 2016 and says it has more than 9 years of hydrophilic catheter R&D and production experience. - The company says its products are distributed to more than 25 countries across North America, Europe, the Middle East, Southeast Asia and Latin America. - The company offers OEM and ODM programs across CH06 to CH24 sizes, multiple catheter lengths, four tip configurations and PVC or TPU tubing. - Private labeling, custom packaging and tailored product specifications are available. - DAXAN says the Coatapex Hydrolyx platform includes super-hydrophilic surface activation, lubricious friction management, antimicrobial properties, anti-encrustation and anti-thrombogenic function. - The coating is described as a PVP-based formulation with coefficient of friction as low as 0.02 and stable superlubricity for more than 24 hours after activation. - The coating technology is also linked to Patent Nos. ZL201811203221.3, ZL202210283147.0, ZL202110292008.X and ZL202310512495.5.

Between the lines: - The launch is as much a manufacturing and sourcing pitch as a product announcement. - DAXAN is emphasizing measurable coating performance, multi-region regulatory files and customization to appeal to importers that need lower supplier risk. - The company is also trying to differentiate DuroFlex from unisex catheter designs by stressing male-specific tip geometry. - The broad OEM program suggests DAXAN wants to serve both branded distributors and private-label buyers with one production platform.

What's next: - DAXAN is directing buyers to its official website for product specifications, OEM program details and regulatory documentation. - The company is also taking inquiries through its contact page at the inquiry page. - DAXAN’s LinkedIn presence is available at the company’s social profile.

The bottom line: - DuroFlex is being marketed as a male-focused intermittent catheter with verifiable coating claims, regulatory coverage and OEM flexibility built in.