Xinyang Yihe Non-woven Co., Ltd.

Xinyang Yihe Non-woven Co., Ltd. specializes in single-use protective and sterile barrier garments. Their product line includes surgical caps, isolation gowns, lab coats, face masks, coveralls, shoe covers, sleeve covers, bed sheets, beard covers, and disposable shorts. These items are designed for medical and laboratory settings to provide contamination control and infection prevention.

The company is based in China. While location influences regulatory pathways, their devices are classified as Class I, which typically requires fewer pre-market authorizations in many jurisdictions. Their products are registered in global databases like EUDAMED (for EU compliance) and the FDA’s UDI system, ensuring traceability and regulatory transparency.

Devices from Xinyang Yihe are listed in EUDAMED (the EU’s medical device registry) and the FDA’s UDI system (for U.S. compliance). These registries are used to track device information for transparency, traceability, and regulatory oversight. Listing in these systems helps ensure compliance with global medical device regulations, particularly for Class I items that still require identification and reporting.

All devices manufactured by Xinyang Yihe fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as single-use protective garments, which pose minimal risk to patients or users. Class I devices often undergo simplified regulatory processes but still require compliance with manufacturing standards and, in some cases, registration in global databases like EUDAMED or FDA UDI.