Wuhan Sitaili Medical Apparatus Development Co., Ltd.

Wuhan Sitaili Medical Apparatus Development Co., Ltd. manufactures ostomy care products, including multiple-piece and one-piece intestinal ostomy bags (open-ended), one-piece urostomy bags (closed-ended), ostomy bag protectors, ostomy convexity inserts, ostomy paste, adhesive remover wipes, and related systems such as one-piece and two-piece colostomy bags and one-system urostomy bags. These products are designed for managing bodily waste following surgical procedures involving the urinary or digestive tracts.

Wuhan Sitaili Medical Apparatus Development Co., Ltd. is based in China, as indicated by the country code CN in the device data. The company's manufacturing and operational activities are located within China, though specific city or facility details are not provided in the source information.

The devices manufactured by Wuhan Sitaili Medical Apparatus Development Co., Ltd. are listed in the EUDAMED and FDA UDI registries. These listings indicate that the company's devices have been registered for market surveillance and unique device identification purposes in the European Union and the United States, respectively, but do not imply approval or clearance of the devices themselves.

The devices manufactured by Wuhan Sitaili Medical Apparatus Development Co., Ltd. are classified as Class I under medical device classification systems. This classification indicates that they are considered low-risk devices, typically subject to general controls such as labeling, manufacturing practices, and post-market surveillance, but not requiring premarket approval or extensive clinical data for market entry.