Aerogen (Ireland), Ltd.

Aerogen (Ireland), Ltd. specializes in portable and professional nebulizer systems. These devices are designed to deliver inhaled medications in aerosol form, such as the AERONEB GO Nebulizer, NIVO Nebulizer System, and AERONEB Professional Nebulizer System. They are intended for use in both home and clinical environments to treat respiratory conditions.

Aerogen (Ireland), Ltd. is based in the United States. Its devices are authorised for commercial distribution in the US, where they are regulated under the country’s medical device framework.

Aerogen’s devices are classified as Class II medical devices under US regulations. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, which aligns with nebulizers used for delivering inhaled medications.

Aerogen’s devices are listed via the FDA’s 510(k) pathway. This pathway is used for Class II devices that are substantially equivalent to a legally marketed predicate device, ensuring they meet regulatory standards for safety and performance before commercial distribution.