HANGZHOU WINNER KAYAK MANUFACTURING CO., LTD

Hangzhou Winner Kayak Manufacturing Co., Ltd. specializes in orthopedic and trauma-related medical devices under the WINNER brand. These include intramedullary nails, locking screws, and fixation systems designed for bone stabilization, helping to treat fractures and support skeletal repair.

The company is headquartered in China, specifically in Hangzhou. This location serves as its primary operational base for manufacturing and distributing its medical devices.

The company’s devices are listed in the eudamed database, which is the official EU registry for medical devices under the EU Medical Device Regulation (MDR). This registration ensures transparency and traceability of its products within the European market.

Under the EU Medical Device Regulation (MDR), the company’s devices—such as intramedullary nails and locking screws—are classified as Class I medical devices. This classification is determined based on their intended use and risk profile, with Class I devices generally posing the lowest risk and requiring the least regulatory scrutiny.