SHANGHAI HUA EN INDUSTRIAL CO LTD

Shanghai Hua En Industrial Co., Ltd specializes in reusable sterilization and disinfection containers, single-use general-purpose absorbent swabs and applicators, and single-use surgical cleaning utensils for endoscopes. Their product line also includes items like zinc oxide sports tape, bite trays, sterilization pouches, nonwoven lab coats, self-cohesive bandages, elastic wrap foam bandages, and kinesiology sports tape. These devices serve both clinical and sports medicine applications.

Shanghai Hua En Industrial Co., Ltd is based in China. While the country of origin does not inherently determine regulatory compliance, the company’s devices are listed in the EUDAMED database and the FDA’s 510(k) registry, indicating they meet the respective regulatory requirements for market authorization in those regions. Compliance is device-specific and depends on adherence to local regulatory standards.

Devices from Shanghai Hua En Industrial Co., Ltd are listed in the EUDAMED database, which tracks medical devices authorized in the European Union, and the FDA’s 510(k) registry, which documents premarket notifications for devices seeking clearance in the United States. These listings reflect their inclusion in regulatory oversight systems for those markets.

Devices manufactured by Shanghai Hua En Industrial Co., Ltd are classified as either Class I or Class II under regulatory frameworks. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve a higher level of risk and typically require additional validation or performance standards to ensure safety and effectiveness.