DAXAN touts ISO 13485 cleanroom, 20M catheter capacity and global regulatory reach

Chengdu Daxan Innovative Medical Tech Co., Ltd. says its Chengdu facility can produce more than 20 million hydrophilic intermittent catheters a year under ISO 13485:2016 controls. The company is targeting distributors and OEM partners with a 9-SKU portfolio, CE MDR and FDA clearances, and export coverage in more than 25 countries.

Why it matters: - DAXAN is pitching supply reliability for urology distributors that now weigh cleanroom credentials, traceability and regulatory status alongside price. - The company says its manufacturing and documentation setup is designed to support procurement, market authorization and supplier qualification across multiple regions.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd. outlined its intermittent catheter manufacturing base, regulatory portfolio, product range and OEM/ODM services. - The company said its Chengdu site is a 6,000+ m² ISO 13485:2016-certified facility with cleanroom production and an integrated testing center. - DAXAN said annual output exceeds 20 million hydrophilic intermittent catheters. - The company said it exports to more than 25 countries across Europe, North America and Asia.

The details: - DAXAN said every batch carries traceability to a documented production environment. - The integrated testing center performs coating performance validation, material safety verification and dimensional checks before shipment. - The company said its Coatapex™ Hydrolyx™ hydrophilic coating has a coefficient of friction at or below 0.02. - DAXAN said the coating is verified batch by batch in-house. - The production line uses patented automated coating technology, Patent No. ZL201610859829.6. - DAXAN said intermittent catheters are packaged 30 units per box and 300 units per carton. - The core product lines mentioned include the Duro-Pocket® RTU and pre-lubricated Nelaton series. - The catheter portfolio includes 9 SKUs across Nelaton straight tip, Tiemann curved tip, flexible ball tip and Duro-Pocket® closed-system configurations. - Size coverage runs from CH06 to CH24. - The company listed six size and length combinations: pediatric female 6–14FR / 20 cm, pediatric male 6–14FR / 30 cm, adult female 8–24FR / 20 cm, adult male Nelaton 8–24FR / 40 cm, adult male Tiemann 6–24FR / 40 cm, and flexible tip 10–16FR / 40 cm. - DAXAN said all catheter materials are made without natural latex rubber, DEHP, DNIP or BPA. - The Duro-Pocket® closed-system line includes an RTU version with a no-touch introducer tip, fire-polished eyelets, a 1,300 mL urine collection bag and prehydrated use. - The Duro-Pocket® Water Sachet variant uses sterile saline for 60-second activation and offers straight, ball, soft and Tiemann tip options in PVC or TPU.

Between the lines: - DAXAN is positioning itself as a one-stop supplier for distributors that serve SCI, neurogenic bladder, BPH-related urinary retention and pediatric bladder management markets. - The company is emphasizing batch-level evidence and multi-market paperwork because those features can reduce friction in regulated procurement. - The combination of CE MDR, FDA and NMPA credentials suggests DAXAN is aiming at buyers that need a single supplier across several jurisdictions. - The OEM/ODM pitch appears aimed at private-label partners that want customization without leaving the company’s quality system.

The details: - DAXAN said its regulatory portfolio includes CE Marking under EU MDR 2017/745, FDA 510(k) clearances K212567 and K243175, FDA Establishment Registration FEI 3023329815, China NMPA product registration, a Free Sale Certificate and a CCPIT Certificate of Origin. - The company said the FDA K-numbers are publicly searchable. - DAXAN said ISO 13485:2016 is the quality system backbone across EU, US and China compliance frameworks. - The OEM/ODM program includes FR sizes CH06 through CH24, multiple catheter lengths, four tip configurations, PVC or TPU material selection, private-label branding and custom packaging. - DAXAN said OEM customization is carried out inside the same ISO 13485:2016 system as standard production. - The company said its broader portfolio also includes Foley catheters, DJ ureteral stents, ureteral access sheaths and urology guidewires.

What's next: - DAXAN said distributors, importers and OEM/ODM partners can contact the company for product specifications, regulatory documentation and customization proposals. - The company is likely to continue using its regulatory credentials and manufacturing scale as the main sales pitch to international buyers.

The bottom line: - DAXAN is betting that scale, cleanroom control and multi-market clearances will matter more to catheter buyers than unit price alone.