Hainwise Medical Technology Co., Ltd.

Hainwise Certification
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Hainwise Certification

Introduction

Our team has more than 10 years of professional R&D experience in medical guidewires and catheters. Hainwise Medical Technology Co., Ltd. operates under a robust EN ISO 13485 certified quality management system, ensuring consistent product quality, traceability, and compliance with international regulatory standards.

Our goal is to become the most valuable brand and a leading high-tech medical technology company in the world, delivering products that meet the highest standards of performance, safety, and regulatory compliance, and supporting customers worldwide.

Quality & Compliance Assurance

  • All Hainwise guidewires and catheters are manufactured under rigorous quality control processes, ensuring consistent performance and safety.

  • Batch traceability and validated production processes guarantee reliability across all products.

  • Our quality and regulatory systems support both off-the-shelf products and custom/OEM solutions.

Contact Sales for Compliance Documentation – Our team can provide regulatory details, OEM capabilities, and technical support.

EN ISO 13485 Quality System Certificate

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_FSC

Angiography Guidewire_Registration Certificate