PENO LLC

PENO LLC specializes in electric nasal aspirators, which are battery-powered devices designed to clear mucus from the noses of infants and young children. These products are intended for home use to help relieve congestion in babies and toddlers. The company focuses primarily on this category of devices.

PENO LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the FDA’s system. This means their products are evaluated and, if authorized, listed in the FDA’s Unique Device Identifier (UDI) database.

PENO LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for regulatory and market surveillance purposes.

PENO LLC’s electric nasal aspirators fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The specific classification depends on factors like design complexity and potential health impact.