DAXAN touts triple-market catheter certifications for importers

Chengdu Daxan Innovative Medical Tech Co., Ltd. says its DAXAN brand holds CE MDR, FDA 510(k), and China NMPA credentials, positioning the company as a single-source catheter OEM supplier for buyers in Europe, the U.S. and Asia-Pacific. The company says its cleanroom capacity, export documentation and private-label OEM options are meant to simplify supplier qualification and market entry.

Why it matters: - International catheter importers often need separate compliance evidence for Europe, the U.S. and China before a supplier can move into qualification. - DAXAN is pitching a single-manufacturer model that combines product clearance, facility registration and export paperwork for multi-market sourcing. - The company says that setup can reduce duplication in regulatory review for distributors, brand owners and OEM partners.

What happened: - Chengdu Daxan Innovative Medical Tech Co., Ltd., established in Chengdu in 2016, promoted its DAXAN brand as a medical catheter OEM supplier with regulatory coverage across the EU, U.S. and China. - The company said it holds CE Marking under EU MDR 2017/745, FDA 510(k) clearances K212567 and K243175, and China NMPA registration. - DAXAN said it also holds FDA Establishment Registration FEI 3023329815. - The company said it operates a 6,000 m² ISO 13485:2016-certified cleanroom with an integrated testing center. - DAXAN said annual output exceeds 20 million hydrophilic catheters. - The company said it exports to more than 25 countries and serves customers across Europe, North America and Asia-Pacific.

The details: - DAXAN said its CE MDR certification uses the Full Quality Assurance pathway under EU MDR 2017/745. - The company said the certification covers hydrophilic-coated intermittent catheter product lines. - DAXAN said the Full Quality Assurance route covers design development, production quality systems, batch production records, post-market surveillance and technical documentation review. - The company said intermittent catheters are Class IIa medical devices under MDR 2017/745. - DAXAN said its FDA clearance K212567 covers hydrophilic-coated intermittent catheters. - The company said FDA clearance K243175 covers its TPU intermittent catheter series. - DAXAN said both K-numbers are searchable in the FDA 510(k) database. - The company said FEI 3023329815 is searchable in the FDA facility registry. - DAXAN said its China NMPA registration covers product standards conformity, quality system assessment and post-market monitoring requirements. - The company said it also holds a Free Sale Certificate and a CCPIT Certificate of Origin. - DAXAN said the FSC supports export eligibility outside the EU and U.S., while the CCPIT document supports customs and tariff documentation. - The company said its OEM program covers French sizes CH06 to CH24. - DAXAN said four tip types are available: Nelaton straight, Tiemann coude, ball and flexible. - The company said materials include medical-grade PVC and DEHP-free, BPA-free TPU. - DAXAN said private-label packaging can be customized by brand, language and distribution unit. - The company said its hydrophilic coating platform is Coatapex™ Hydrolyx™. - DAXAN said the coating is a PVP-based formulation designed for low surface friction and stable lubricity after activation. - The company said the coating platform is supported by patent numbers ZL201610861058.4 and ZL201811203221.3. - DAXAN said its private-label product families include hydrophilic Nelaton straight-tip catheters, the Duro-Pocket® closed-system catheter line in RTU and water sachet-activated formats, and the DuroFlex™ flexible-tip ISC catheter for male anatomy applications. - The company said product documentation, regulatory packages and OEM details are available at the company’s website. - DAXAN also listed a LinkedIn page at the company’s social profile.

Between the lines: - The message is aimed less at end users than at procurement and regulatory teams that need a supplier to clear multiple market-entry hurdles at once. - DAXAN is positioning ISO 13485 as the shared quality backbone behind its EU, U.S. and China compliance claims. - The company’s emphasis on searchable identifiers, facility registration and export certificates signals a focus on documentation that can be verified during supplier qualification.

What's next: - DAXAN said importers can request product specifications, regulatory documentation and OEM program details directly through its website. - The company appears to be using its compliance stack and private-label range to compete for framework contracts and multi-SKU distribution programs.

The bottom line: - DAXAN is selling a combined regulatory-and-manufacturing package: triple-market compliance, sizable output and customizable catheter OEM programs in one source.