DAXAN touts closed-system catheter line with dual FDA clearances

Chengdu Daxan Innovative Medical Tech says its Duro-Pocket closed-system catheter line is built around a no-touch introducer tip, CE marking and two FDA 510(k) clearances. The company is pitching the product range to distributors and importers that now treat CAUTI risk and regulatory documentation as core sourcing criteria.

Why it matters: - Closed-system catheter sourcing is increasingly tied to catheter-associated urinary tract infection, or CAUTI, risk. - DAXAN is positioning the Duro-Pocket line as a sealed catheter option for procurement teams that want lower contamination exposure and multi-market regulatory coverage. - The combination of CE marking, FDA clearances and China NMPA registration can simplify market entry for distributors.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd. highlighted its Duro-Pocket closed-system catheter range for B2B medical device procurement. - The Duro-Pocket line carries CE marking under EU MDR 2017/745 and FDA 510(k) clearances K212567 and K243175. - DAXAN said the product line is designed around a no-touch introducer tip and a sealed catheter assembly. - The company included product information and OEM inquiry channels at the company’s website.

The details: - The RTU ready-to-use version uses a fully enclosed introducer tip that stays sealed until use. - DAXAN said the no-touch introducer tip is part of patent ZL201821674844.4, and the activation-free hydrophilic coating technology is covered by patent ZL201811203221.3. - A pull ring removes the protective cap from the pre-lubricated introducer tip. - The catheter body uses medical-grade TPU. - Available sizes include pediatric 6 to 14 FR, female 8 to 18 FR and male 8 to 18 FR. - Packaging comes in 30 units per box and 300 units per carton. - The catheter arrives prehydrated and does not require additional lubrication before use. - Fire-polished eyelets are designed to reduce friction during insertion and withdrawal. - An integrated urine collection bag holds up to 1,300 mL. - A Water Sachet variant uses a sterile saline sachet that activates in about 60 seconds. - The Water Sachet version offers straight, ball, soft and Tiemann tips in PVC or medical-grade TPU. - The Water Sachet version uses the same 30-unit and 300-unit packaging formats. - DAXAN said the line is manufactured in an ISO 13485:2016-certified facility with more than 6,000 square meters of cleanroom and testing space. - The company said annual output exceeds 20 million hydrophilic catheters. - FDA Establishment Registration FEI 3023329815 is publicly verifiable.

Between the lines: - DAXAN is not just selling product features; it is selling compliance readiness as a procurement advantage. - The dual FDA 510(k) clearances and EU MDR route suggest the company is targeting importers that sell into multiple regions. - The closed-system format and no-touch tip are the main clinical selling points, while manufacturing scale and OEM customization are the commercial selling points. - The broader pitch is aimed at distributors that want a private-label or framework-contract supplier without restarting the regulatory process from zero.

What's next: - DAXAN is seeking OEM and ODM business across its catheter portfolio. - The company said customization options include PVC or medical-grade TPU, CH06 through CH24 sizes, multiple lengths and private-label packaging. - DAXAN said its products currently reach distribution partners in more than 25 countries. - The company is leaning on its regulatory documentation, capacity and closed-system design to win additional import and distribution contracts.

The bottom line: - DAXAN is pitching Duro-Pocket as a sealed, no-touch catheter platform built for buyers that want infection-control features and verifiable regulatory credentials in one package.