What class of medical device does a disposable medical drape belong to?

Medical underpads are classified as Class II medical devices. These devices carry moderate risk and require strict control and management to ensure their safety and effectiveness. They are primarily used in clinical settings for protection and isolation against contamination, directly relating to patient safety. If substandard products cause infections, skin injuries, or similar issues, prompt medical attention is recommended.

The classification of Class II medical devices centers on risk level and intended use. Medical underpads come into direct contact with patients' skin or mucous membranes during medical procedures such as surgery or nursing care. They must possess critical performance features such as sterility and leak resistance. Failure to meet quality standards may lead to cross-infection, resulting in a higher risk level compared to Class I devices.

In China, Class II medical devices are subject to product registration management. Manufacturers must obtain a medical device production license, and products must pass technical testing and clinical verification, complying with national medical device standards. After market release, they are also subject to regular quality supervision inspections to ensure product consistency and safety.

When purchasing, check the product registration certificate number and manufacturer's qualifications. Before use, inspect packaging integrity and expiration date. Store in a dry, well-ventilated area to prevent contamination. Use according to medical operation guidelines and dispose of as medical waste following proper classification protocols after use.