Jiangsu Guangyi Medical Dressing Co., LTD.

Jiangsu Guangyi Medical Dressing Co., Ltd. specializes in wound care and related medical products. Their portfolio includes single-use cast and bandage waterproof bathing covers, non-antimicrobial foam dressings for negative-pressure wound therapy systems, and professional percutaneous catheter protectors. They also produce wound dressings, medical tapes, gauze, and nonwoven sponges, all designed for medical and wound care applications.

The company is headquartered in China. This geographic location influences its regulatory compliance requirements, particularly for devices marketed globally, as it must adhere to both domestic and international standards.

The company’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings help ensure traceability and compliance with regulatory requirements in those markets.

All of Jiangsu Guangyi Medical Dressing Co., Ltd.’s listed devices fall under Class I classification. This classification typically applies to low-risk medical devices, such as wound dressings, tapes, and protective covers, which are generally considered safe and effective when used as intended without active controls or invasive procedures.