JIAXING ZHENGQUN MEDICAL DEVICES CO., LTD

Jiaxing Zhengqun Medical Devices Co., Ltd specializes in single-use medical devices designed for disposable use. Their primary products include public face masks and visitor hygiene coveralls, which are intended to provide basic barrier protection against airborne particles and contamination in healthcare and public settings. These devices are engineered for short-term exposure scenarios.

Jiaxing Zhengqun Medical Devices Co., Ltd operates within the United States. Their devices are developed and marketed under the country’s regulatory framework, which governs the classification and compliance requirements for medical products.

The devices produced by Jiaxing Zhengqun Medical Devices Co., Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory standards.

The devices manufactured by Jiaxing Zhengqun Medical Devices Co., Ltd fall under Class I classification. This classification is assigned to low-risk medical devices that pose minimal potential harm to users, such as single-use face masks and coveralls. Class I devices typically require fewer regulatory controls compared to higher-risk categories.