Temperature-monitoring indwelling urethral drainage catheter

This category includes sterile, flexible urinary catheters designed for long-term indwelling use, featuring an inflatable balloon to secure placement in the bladder and an integrated temperature sensor for continuous core body temperature monitoring. These devices are inserted through the urethra and allow simultaneous urinary drainage and temperature measurement, commonly used during or after surgery or in patients with urinary obstruction or paralysis.

As single-use devices, they are intended for one-time insertion and removal, and are typically supplied sterile for immediate clinical use. Regulation focuses on their combined functions as both a urinary drainage device and a temperature-monitoring tool, with classification based on their intended use and risk profile in accordance with applicable medical device regulations.