DAXAN highlights 20M-catheter capacity and ISO 13485 cleanroom in China

Chengdu Daxan Innovative Medical Tech says its Chengdu facility produces more than 20 million hydrophilic intermittent catheters a year under ISO 13485:2016 controls. The company is pitching its regulatory clearances, closed-system products and OEM/ODM services to distributors and importers in urology care.

Why it matters: - DAXAN is positioning manufacturing scale, cleanroom controls and regulatory documentation as the main buying criteria for global intermittent catheter procurement. - Distributors and importers in regulated markets often need batch traceability, audited quality systems and multi-market clearances before they can place or renew supply contracts. - The company says its setup is designed to support urology care supply chains across Europe, North America and Asia.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd. outlined its intermittent catheter manufacturing operation in Chengdu, Sichuan, China. - The facility covers more than 6,000 m² of ISO 13485:2016-certified cleanroom and integrated testing space. - DAXAN says annual output exceeds 20 million hydrophilic intermittent catheters. - The company also promoted its OEM/ODM program for distributors, importers and private-label partners. - DAXAN included contact information for product specifications and customization requests at the company's announcement. - The company also listed its LinkedIn page at DAXAN on LinkedIn.

The details: - DAXAN says every production batch is traceable to a documented manufacturing environment. - The on-site testing center checks coating performance, material safety and dimensional specifications before shipment. - The company says its Coatapex™ Hydrolyx™ hydrophilic coating has a coefficient of friction of 0.02 or lower. - DAXAN says that coating verification is done batch by batch in-house. - The company says the catheters are manufactured without natural latex rubber, DEHP, DNIP or BPA. - DAXAN says its intermittent catheter portfolio includes 9 SKUs across four tip configurations: Nelaton straight tip, Tiemann curved tip, flexible ball tip and Duro-Pocket® closed system. - The portfolio covers CH06 to CH24 sizes and six size configurations for pediatric and adult use. - Pack sizes are 30 units per box and 300 units per carton across the main product lines. - The product lines include the Duro-Pocket® RTU and pre-lubricated Nelaton series. - DAXAN says the Duro-Pocket® RTU uses a no-touch introducer tip, fire-polished eyelets and a 1,300 mL urine collection bag. - The Duro-Pocket® Water Sachet variant uses sterile saline activation in 60 seconds and comes in straight, ball, soft and Tiemann tip options. - That variant is available in PVC or TPU. - DAXAN says its automated coating technology is covered by Patent No. ZL201610859829.6. - The company says it has exported to more than 25 countries. - DAXAN says its product range also includes Foley catheters, DJ ureteral stents, ureteral access sheaths and urology guidewires.

Between the lines: - DAXAN is bundling manufacturing capacity, compliance paperwork and customization into one supplier pitch for regulated healthcare buyers. - The emphasis on CE MDR, FDA 510(k), NMPA registration and ISO 13485 suggests the company is targeting procurement teams that need documentation ready for audits and market access reviews. - The closed-system catheter messaging points to infection-control pressure in urology care, especially for self-catheterizing patients. - The export and OEM/ODM claims indicate DAXAN wants to be seen as a long-term contract manufacturer, not only a catalog supplier.

What's next: - DAXAN is inviting distributors, importers and OEM/ODM partners to request product specifications, regulatory documents and customization proposals. - The company is likely to continue using its capacity, certifications and private-label options to pursue more international distributor accounts. - Buyers can independently verify the FDA 510(k) clearances K212567 and K243175 in the public database.

The bottom line: - DAXAN is betting that scale, traceable production and multi-market approvals will matter more than price alone in the intermittent catheter market.