Chengdu, Sichuan Jul 24, 2026 (Issuewire.com) - Intermittent catheterization is the established clinical standard for patients managing spinal cord injury, neurogenic bladder, and urinary retention over the long term -- often multiple times daily, indefinitely. The catheter a patient uses each day is precisely the product standard the sourcing team selected. Chengdu Daxan Innovative Medical Tech Co., Ltd. announces the global availability of its Nelaton straight-tip hydrophilic catheter range for distributors, importers, and OEM partners. As a Nelaton Hydrophilic Catheter Supplier, DAXAN structures the line around three sourcing fundamentals: measurable coating friction performance through its proprietary Coatapex™ Hydrolyx™ coating platform, six standard size configurations covering pediatric through adult populations, and a regulatory registration stack spanning CE MDR 2017/745, dual FDA 510(k) clearances, and China NMPA registration.
The Nelaton Catheter in Intermittent Catheterization: Clinical Applications and Distributor Sourcing Criteria
The Nelaton straight-tip design is the most broadly indicated catheter format for intermittent catheterization, suited to patients with spinal cord injury, neurological dysfunction causing neurogenic bladder, and non-neurological conditions including benign prostatic hyperplasia and urinary retention. These patient populations catheterize routinely and repeatedly -- placing consistent demands on coating durability, insertion comfort, and catheter-to-catheter performance stability.
Distributor evaluation criteria for a hydrophilic Nelaton intermittent catheter supplier have evolved accordingly. Price comparison at the unit level has given way to a system-level audit that weighs coating coefficient of friction data, catalog coverage across all patient age groups and anatomy types, and a regulatory documentation package aligned with target-market clearance requirements. The supplier who satisfies all three criteria within a single manufacturer relationship removes a significant layer of procurement complexity for distributors coordinating across multiple markets.
Coatapex™ Hydrolyx™ Hydrophilic Coating: COF 0.02 and Lubricity Sustained Beyond 24 Hours
The Coatapex™ Hydrolyx™ hydrophilic coating is formulated on a polyvinylpyrrolidone (PVP) chemistry platform. Its coefficient of friction is measured as low as 0.02, with lubricity stability maintained beyond 24 hours. For a patient who catheterizes four to six times daily, a consistent low-friction surface from the first use of the day through the last reduces cumulative urethral mucosal friction exposure and supports long-term catheterization comfort. The coating technology is supported by DAXAN Patent Nos. ZL201610861058.4, ZL201811203221.3, and ZL201810063901.3.
The coating formulation contains no natural latex, DEHP, DNIP, or BPA. This material profile meets the substance-restriction requirements applicable under EU MDR and US FDA regulatory frameworks and opens distribution into markets with specific allergen and plasticizer restrictions. The combination of a quantified friction coefficient, a sustained-lubricity specification, and confirmed material safety constitutes the core performance evidence base the Nelaton range carries into distributor qualification reviews.
DAXAN's Straight-Tip Range: Six Standard Configurations from Pediatric to Adult Populations
The Nelaton hydrophilic catheter range from Chengdu Daxan Innovative Medical Tech Co., Ltd. is available in six standard configurations: Pediatric Female at 6 to 14FR and 20 cm, Pediatric Male at 6 to 14FR and 30 cm, Adult Female at 8 to 24FR and 20 cm, Adult Male Nelaton at 8 to 24FR and 40 cm, Adult Male Tiemann at 6 to 24FR and 40 cm, and Flexible Tip at 10 to 16FR and 40 cm. The French size range spans from 6FR to 24FR, with catheter lengths from 20 cm to 40 cm.
The presence of Tiemann and flexible-tip configurations alongside the standard Nelaton line means distributors can address patients with prostatic obstruction or urethral stricture that requires an angled or adaptive tip -- within the same product family and supplier relationship. This structural completeness allows a distributor to build a comprehensive intermittent catheterization catalog, from pediatric female to adult male Tiemann configurations, from a single qualified source.
Material Safety and Design Engineering: Latex-Free, DEHP-Free TPU with Non-Touch Gripper and Universal Connector
Catheter bodies are produced in medical-grade thermoplastic polyurethane, confirmed free of natural latex, DEHP/DNIP, and BPA. Building on this material foundation, the Coatapex™ Hydrolyx™ platform is structured around five functional properties: super-hydrophilic surface activation, lubricious friction management, antimicrobial properties (Patent No. ZL202110292008.X)—a surface designed to reduce bacterial adhesion, anti-encrustation—a surface designed to resist encrustation, and anti-thrombogenic function (Patent No. ZL202310512495.5)—a surface designed to reduce thrombogenic potential. Together, these functions address catheter-associated risks that extend well beyond the insertion event, including encrustation buildup that can degrade performance over repeated catheterization cycles and thrombogenic surface interactions relevant to extended-use contexts.
An extended textured gripper sleeve is integrated into each catheter unit, allowing the user to hold the catheter without contacting the insertion shaft and maintaining hygienic technique without requiring a separate sleeve accessory. The catheter tip is bullet-shaped for smooth initial urethral entry, and drainage holes are positioned to minimize urethral wall contact during drainage.
A universal funnel connector provides compatibility with standard urine collection bags and toilet adapters, supporting both clinical-setting and home-use application. Individual packaging uses an easy-open aluminum foil peel pouch with an adhesive hanging sticker, enabling upright storage in a home setting. Each catheter is supplied sterile and is intended for single use.
Three Nelaton Sub-Products: Without Water Pouch, Ready-to-Use, and Water Pouch Variants for Distributor Portfolio Flexibility
DAXAN supplies three Nelaton sub-product configurations to support distinct market price points and end-user scenarios. The Hydrophilic Nelaton Straight Catheter without water pouch uses the Coatapex™ Hydrolyx™ coating's pre-activation lubricity, eliminating a separate water component while maintaining the full coating performance specification -- a cost-effective choice for markets where price sensitivity is a key consideration. The Pre-Lubricated Nelaton Ready-to-Use Catheter arrives fully pre-lubricated and requires no additional preparation steps; it incorporates hot-polished eyelets to reduce mucosal contact risk and is available in sizes from 8 to 24FR for both female and male patients. The Disposable Hydrophilic Nelaton Catheter with Water Pouch integrates a self-contained water pouch, designed for travel or environments where running water is not accessible.
All three configurations are produced under the same ISO 13485:2016 quality management system and carry the same Coatapex™ Hydrolyx™ coating platform, allowing distributors to tier their offering by price point and use scenario without introducing a secondary supplier.
DAXAN's ISO 13485:2016 Manufacturing Credentials, Market Registrations, and OEM Customization Services
DAXAN operates a 6,000 square meter ISO 13485:2016-certified cleanroom and testing center in Chengdu, with an annual hydrophilic catheter production capacity of more than 20 million units. Since its founding in 2016, Chengdu Daxan Innovative Medical Tech Co., Ltd. has accumulated more than nine years of dedicated catheter research and production experience, with products distributed to more than 25 countries. Manufacturing at this scale -- with a fully integrated testing center on the same ISO-certified floor -- supports the batch-to-batch consistency and documentation traceability that international distributors require for ongoing supplier audits.
The Nelaton catheter range carries CE Marking under EU MDR 2017/745 via the Full Quality Assurance conformity pathway, FDA 510(k) clearance K212567 for the hydrophilic intermittent catheter, and FDA 510(k) clearance K243175 for TPU-based catheter products. The FDA Establishment Registration number FEI 3023329815 is independently verifiable through the FDA database. China NMPA/CFDA registration is additionally held, alongside a Free Sale Certificate covering multiple export markets and a Certificate of Origin issued by CCPIT. Together, these registrations allow distributors in the EU, the United States, China, and additional markets to clear customs and enter local procurement channels using documentation provided directly from the manufacturer.
OEM and ODM customization services extend across the full FR CH06 to CH24 size range, with support for multiple catheter lengths, four tip-type configurations -- Nelaton, Tiemann, flexible, and ball tip -- choice of PVC or TPU material, and private labeling for brand distributors and importers.
Distributors, importers, and OEM partners seeking product specifications, regulatory documentation, or sample evaluation for the DAXAN Nelaton hydrophilic catheter range may submit inquiries directly through the official website: https://www.daxanmedical.com/
Media Contact
Chengdu Daxan Innovative Medical Tech Co., Ltd. *****@daxanmed.com http://www.daxanmedical.com
