Hainwise Medical Certifications - Quality and Compliance Standards

Hainwise Certification

Hainwise Medical Technology Co., Ltd. operates under an EN ISO 13485 certified quality management system, ensuring full traceability, validated production processes, and compliance with international regulatory standards. With over a decade of specialized experience in guidewire and catheter development, all products are manufactured under rigorous quality control protocols to ensure consistent performance, safety, and reliability. Our regulatory and quality systems support both standard product lines and customized OEM solutions, with compliance documentation and technical details available upon request.

Hydrophilic Guidewire, Zebra Guidewire FDA Free Sale Certificate_CFG Certificate

Disposable Urinary Tract Zebra Guidewire_FSC

Disposable Urinary Tract Zebra Guidewire_Registration Certificate

Disposable Urinary Tract Hydrophilic Guidewire_FSC

Disposable Urinary Tract Hydrophilic Guidewire_Registration Certificate

Angiography Guidewire_Registration Certificate