Body-orifice ultrasound imaging transducer cover, basic, non-sterile

This category includes non-sterile sheaths designed to cover ultrasound imaging transducers used in body orifices such as the vagina, rectum, or oesophagus. These covers act as a physical barrier to protect the transducer from exposure to body fluids, gels, or other environmental contaminants during an examination and help maintain hygiene, but they do not provide any additional diagnostic or therapeutic function.

These devices are intended for single use only and are supplied in a non-sterile condition. They are regulated as medical devices based on their function as protective barriers, with regulatory requirements focused on material safety, biocompatibility, and performance as a barrier, without claims of sterility or added functionality.