ZHEJIANG XINYE MEDICAL DEVICE CO. ,Ltd.

Zhejiang Xinye Medical Device Co., Ltd., located in the Lanxi Economic Development Zone of Zhejiang Province, was established in September 2010 with a registered capital of 5 million yuan. Since its inception, the company has been dedicated to providing integrated services encompassing the design, development, production, and sales of single-use medical devices. The company occupies a total site area of 12,000 square meters, with a gross floor area exceeding 9,600 square meters. Its cleanroom facilities span over 1,200 square meters and have been designed in accordance with the YY0033 "Production Quality Management Specification for Sterile Medical Devices" standards. The company is equipped with advanced and comprehensive production facilities, complete testing infrastructure, a robust team of professional technical personnel, and state-of-the-art manufacturing processes. The company's primary product portfolio includes: Class II products—integrated oxygen delivery devices; single-use humidified nasal oxygen tubes, single-use humidified oxygen masks, single-use nebulizers, single-use moisture-absorbing and condensing humidification catheters, "moisture-heat exchange filters (artificial noses)," and single-use anesthesia ventilator tubing (with collection cups); Class I products—tissue fixatives, breast compression elastic bandages, and oxygen delivery systems; sterilization-related products—oral antibacterial gels, chlorhexidine gluconate mouthwash, probiotic mouthwash, and other sterilization-related product lines; and daily care products—single-use self-heating warm patches (including steam hot compress eye masks, hand and foot warm patches, lumbar and abdominal warm patches, uterine warming patches, and knee pads), medical antipyretic patches, and cold compress patches. Throughout its R&D and production processes, the company strictly adheres to the "Appendix: Sterile Medical Devices" of the "Good Manufacturing Practice for Medical Devices," the "Good Manufacturing Practice for Medical Devices," and the standard YY/T0287-2017 "Medical Devices — Quality management systems — Requirements for compliance with regulations." Disinfection products comply with the health industry standards of the People's Republic of China. The company adheres to the fundamental principles of "quality and reputation," and its quality policy is based on "strict compliance with standards, meticulous manufacturing, safety and efficacy, and attentive service." We provide applicable, safe, and reliable medical products to domestic and international customers. The company strives to develop products that conform to national standards while continuously meeting customer requirements. We are committed to optimizing management across all stages of product development, production, and post-market support, thereby ensuring the clinical safety and efficacy of our products.