Wholesale Ready-to-Use Catheter for Urology Distributors: DAXAN Global OEM ODM Services

(ProNewsReport Editorial):- Chengdu, Sichuan Jul 24, 2026 (Issuewire.com) – As procurement priorities in the global urology supply chain shift from basic product availability toward end-to-end supply system completeness, the choice of a Ready-to-Use Catheter Supplier has become a structuring decision for distributors building durable urology product lines. Chengdu Daxan Innovative Medical Tech Co., Ltd. operating under the brand name DAXAN — has developed a wholesale ready-to-use hydrophilic catheter portfolio designed to meet the operational, compliance, and patient-safety requirements of urology distributors across regulated markets.

Founded in 2016 and backed by more than nine years of hydrophilic catheter manufacturing experience, DAXAN operates from a 6,000+ m² ISO 13485:2016-certified cleanroom facility in Chengdu, China. Annual production capacity exceeds 20 million hydrophilic catheters, and the company’s products are exported to more than 25 countries across Europe, North America, Asia-Pacific, and the Middle East. DAXAN’s ready-to-use lineup — spanning the Duro-Pocket® closed system, the Pre-Lubricated Nelaton, and the DuroFlex flexible-tip catheter — are complemented by a full OEM/ODM private-label service covering FR sizes CH06 through CH24.

Ready-to-Use Catheters: A Growing Priority for Urology Distributors Worldwide

Wholesale purchasing decisions in the intermittent catheterization segment have moved well beyond simple product specification comparison. Ready-to-use intermittent catheters arrive pre-lubricated, prehydrated, or pre-activated at point of manufacture, eliminating the extra preparation steps required by open-system catheters. For hospital procurement and home care channels, this addresses infection control requirements and eases the burden on clinicians and patients performing self-catheterization.

Catheter-associated urinary tract infections (CAUTI) remain a clinically recognized risk in settings where intermittent catheterization is used on a regular or high-frequency basis. Closed-system and no-touch catheter designs have gained significant traction in European and North American markets because they reduce direct manual contact with the catheter surface during insertion. For distributors evaluating wholesale intermittent catheter distributor OEM programs, RTU design integrity, CAUTI-reduction features, and multi-market regulatory clearance have become a core sourcing criterion rather than a secondary consideration.

DAXAN’s Ready-to-Use Catheter Product Lineup: Duro-Pocket®, Pre-Lubricated Nelaton, and DuroFlex

DAXAN’s RTU product range is organized into three distinct lines, each engineered for a specific clinical use case. Together, they span pediatric through adult patient populations, female and male anatomies, and standard through complex self-catheterization scenarios.

The Duro-Pocket® Closed System Intermittent Catheter is the core of DAXAN’s no-touch RTU offering. The Ready-to-Use variant arrives prehydrated, requiring no additional lubrication or water activation at point of use. Its fully enclosed no-touch introducer tip is designed to maintain sterility throughout the insertion process — a detail that directly targets CAUTI risk reduction. Fire-polished eyelets minimize mucosal friction and reduce the potential for tissue irritation during insertion and withdrawal. The integrated urine collection bag holds up to 1,300 mL and is available in multiple sizes. Manufactured from soft, flexible medical-grade TPU, the Duro-Pocket® RTU covers Pediatric (6-14FR), Female (8-18FR), and Male (8-18FR) sizes. Standard wholesale packaging is 30 units per box and 300 units per carton.

The Pre-Lubricated Nelaton Ready-to-Use catheter addresses the broader standard intermittent catheterization market. Manufactured from DEHP-free and BPA-free medical-grade TPU with hot-polished side eyelets, it covers a wide size range from Pediatric Female and Male through Adult Female and Male, spanning 6-24FR. The catheter arrives at the factory pre-lubricated with no additional activation step required, making it well suited to both institutional supply and home care distribution channels.

The DuroFlex Pre-Lubricated Flexible Tip ISC Catheter completes the lineup with a design specifically engineered for male urethral anatomy. Its flexible ball-shaped tip adapts to the natural curves and anatomical contours of the male urethra, reducing insertion resistance in cases of anatomical variation or urethral stricture. Available in sizes 10-16FR and 40 cm length, the DuroFlex features a non-touch gripper sleeve for hygienic single-handed insertion and is packaged in individual sterile aluminum foil pouches with a dual tear-opening design.

OEM/ODM Services: Private-Label Catheter Programs Across CH06-CH24 FR Sizes

DAXAN’s OEM/ODM program allows wholesale distributors and importers to develop private-label ready-to-use hydrophilic catheter lines backed by the same manufacturing infrastructure that supports DAXAN’s own catalogue products. Customization options cover the full FR size range from CH06 through CH24, with multiple tube length configurations, four tip type selections — straight Nelaton, ball-tip, soft-tip, and Tiemann/Coudé — and a choice of PVC or TPU tube material. Private labeling, custom packaging artwork, and outer carton specification are all accommodated within the OEM program.

The coating technology underlying these private-label products is the proprietary Coatapex Hydrolyx hydrophilic coating platform. Formulated from polyvinylpyrrolidone (PVP) chemistry, the Coatapex Hydrolyx coating achieves a coefficient of friction (COF) as low as 0.02 and maintains stable superlubricity for more than 24 hours after activation, supporting clinically meaningful friction reduction for patients who catheterize multiple times daily. The coating platform also incorporates antimicrobial, anti-encrustation, and anti-thrombogenic surface properties, giving private-label distributors a technical specification that goes beyond standard pre-lubricated catheter claims. The coating platform is supported by DAXAN patents covering activation-free super-lubricious coating technology (Patent No. ZL201811203221.3) and a water-based hydrophilic lubricious coating (Patent No. ZL201810063901.3).

With more than nine years of hydrophilic coating OEM manufacturing experience and an active export network spanning over 25 countries, DAXAN provides the production scale, regulatory infrastructure, and customization depth that wholesale intermittent catheter distributor OEM programs require.

Compliance Portfolio: ISO 13485 Cleanroom, CE MDR 2017/745, Dual FDA 510(k), and NMPA

Regulatory compliance is foundational to DAXAN’s positioning as a wholesale medical catheter supplier for global distribution markets. The quality management system is built on ISO 13485:2016 certification, the internationally recognized standard for medical device manufacturing quality, underpinning DAXAN’s regulatory submissions and production controls.

At the market access level, DAXAN holds CE Marking under EU Medical Device Regulation 2017/745, cleared under the Full Quality Assurance route, enabling product registration and distribution across EU and EEA member states. Two separate FDA 510(k) clearances cover the US market: K212567 for the hydrophilic intermittent catheter product line, and K243175 for the TPU intermittent catheter line. DAXAN’s FDA Establishment Registration (FEI 3023329815) is independently verifiable through the FDA 510(k) database. China NMPA (formerly CFDA) registration addresses domestic Chinese market compliance and provides an additional trust signal for distributors sourcing from China-origin manufacturers. Export documentation includes a Free Sale Certificate and a Certificate of Origin issued by CCPIT.

This triple-market regulatory portfolio — covering the EU, the United States, and China from a single ISO 13485-certified manufacturing site — is a meaningful differentator among China-based intermittent catheter manufacturers, letting importers consolidate multi-market supply under one OEM partner with pre-existing clearances.

Production Scale and Global Reach: 20M+ Units Per Year Exported to 25+ Countries

DAXAN‘s capacity to support wholesale distribution programs is grounded in verifiable production infrastructure. Annual output exceeds 20 million hydrophilic catheters, produced in a 6,000+ m² ISO 13485:2016-certified cleanroom equipped with extrusion, molding, punching, and automated packaging production lines. This scale provides the batch-volume consistency and delivery stability that regional distributors require when building multi-territory urology product portfolios.

Since its founding in 2016, DAXAN has developed an active export network reaching more than 25 countries across Europe, North America, Asia-Pacific, and the Middle East. This distribution breadth reflects nearly a decade of experience managing international shipping, customs documentation, and regional regulatory requirements — experience that supports more predictable lead times for distributor partners entering new markets.

With a verified three-line ready-to-use catheter portfolio, a full-scope OEM/ODM private-label program backed by the Coatapex Hydrolyx coating platform, and a compliance framework spanning EU, US, and China markets, DAXAN offers wholesale urology distributors a single-source manufacturing partner built for the demands of global medical device distribution. Distributors and importers seeking to review product specifications, OEM service terms, or regulatory documentation are invited to visit www.daxanmedical.com

Source :Chengdu Daxan Innovative Medical Tech Co., Ltd.

This article was originally published by IssueWire. Read the original article here.