DAXAN expands Nelaton hydrophilic catheter line for global distributors

Chengdu Daxan Innovative Medical Tech Co., Ltd. says its Nelaton straight-tip hydrophilic catheter range is now globally available for distributors, importers and OEM partners. The company is positioning the line around friction performance, broad size coverage and regulatory clearances across the EU, U.S. and China.

Why it matters: - Intermittent catheterization is a long-term, often multiple-times-daily therapy for patients with spinal cord injury, neurogenic bladder and urinary retention. - A distributor’s catheter choice affects insertion comfort, coating durability and supply complexity across markets. - DAXAN is targeting buyers that need one catheter family to cover pediatric and adult users, plus multiple regulatory regimes.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd. announced global availability of its Nelaton straight-tip hydrophilic catheter range for distributors, importers and OEM partners. - The product line is built around the company’s Coatapex™ Hydrolyx™ coating platform, six standard size configurations and a regulatory package that includes CE MDR 2017/745, dual FDA 510(k) clearances and China NMPA registration. - The company published contact information and product inquiry channels on its website: the company's announcement.

The details: - The Nelaton straight-tip format is positioned for patients with spinal cord injury, neurogenic bladder, benign prostatic hyperplasia and urinary retention. - DAXAN says the Coatapex™ Hydrolyx™ hydrophilic coating is based on PVP chemistry and has a coefficient of friction as low as 0.02. - The coating is designed to maintain lubricity for more than 24 hours. - The coating is backed by DAXAN Patent Nos. ZL201610861058.4, ZL201811203221.3 and ZL201810063901.3. - The formulation contains no natural latex, DEHP, DNIP or BPA. - Catheter bodies are made from medical-grade thermoplastic polyurethane. - The line includes a super-hydrophilic surface, lubricious friction management, antimicrobial properties tied to Patent No. ZL202110292008.X, anti-encrustation properties and anti-thrombogenic function tied to Patent No. ZL202310512495.5. - Each catheter includes an extended textured gripper sleeve to support non-touch handling. - The tip is bullet-shaped, and the drainage holes are positioned to reduce urethral wall contact during drainage. - A universal funnel connector works with standard urine collection bags and toilet adapters. - Packaging uses an easy-open aluminum foil peel pouch with an adhesive hanging sticker. - Each catheter is sterile and intended for single use. - The six standard configurations are Pediatric Female, Pediatric Male, Adult Female, Adult Male Nelaton, Adult Male Tiemann and Flexible Tip. - Size ranges run from 6FR to 24FR, with lengths from 20 cm to 40 cm. - DAXAN says the Tiemann and flexible-tip options are intended to help address prostatic obstruction and urethral stricture within the same product family. - Three sub-product variants are available: without water pouch, ready-to-use and water pouch. - The ready-to-use version is fully pre-lubricated, uses hot-polished eyelets and comes in 8FR to 24FR for female and male patients. - The water-pouch version is designed for travel or places without running water. - All three versions are produced under the same ISO 13485:2016 quality management system.

Between the lines: - DAXAN is using regulatory breadth and catalog depth as a sales argument, not just price. - The pitch is aimed at distributors that want to reduce supplier juggling across adult, pediatric and tip-specific catheter needs. - The company is also trying to differentiate on performance claims that are measurable, such as coefficient of friction and lubricity duration. - DAXAN says its no-latex, no-DEHP, no-DNIP and no-BPA material profile helps it fit markets with allergen and plasticizer restrictions.

What's next: - DAXAN says distributors, importers and OEM partners can request specifications, regulatory documents and samples through its website. - The company is also offering OEM and ODM customization across FR CH06 to CH24, multiple lengths, four tip types, PVC or TPU material choices and private labeling. - DAXAN says it operates a 6,000-square-meter ISO 13485:2016 cleanroom and testing center in Chengdu. - The company says annual hydrophilic catheter production exceeds 20 million units. - DAXAN says products are distributed to more than 25 countries and that the company has been building catheter expertise since 2016. - The product line carries FDA 510(k) clearance K212567 for the hydrophilic intermittent catheter, FDA 510(k) clearance K243175 for TPU-based catheter products, and FDA Establishment Registration number FEI 3023329815. - The company also says it holds China NMPA/CFDA registration, a Free Sale Certificate for multiple export markets and a Certificate of Origin issued by CCPIT.

The bottom line: - DAXAN is packaging a broad intermittent-catheter catalog with documented coatings, multi-market registrations and OEM flexibility to compete for global distributor business.