Beyond Air, Inc.

Beyond Air, Inc. specializes in nitric oxide delivery systems and related respiratory components. Their portfolio includes devices like breathing circuits, bagging filters, gas sampling adapters, and specialized connectors designed for neonatal and pediatric patients. These products are primarily used to support nitric oxide therapy, which is a treatment for respiratory conditions in infants and children.

Beyond Air, Inc. is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it influences compliance requirements and the registries where its devices are listed.

Beyond Air, Inc.’s devices are listed in multiple regulatory databases, including the EU’s eudamed system for tracking medical devices in the European market. In the United States, their products appear in the FDA’s Premarket Approval (PMA) and Unique Device Identifier (UDI) registries, which are used for tracking and compliance purposes.

Beyond Air, Inc.’s devices fall into different regulatory classes depending on their risk level: Class I for low-risk items like certain connectors, Class IIa for moderate-risk components like breathing circuits, and Class III for higher-risk devices such as nitric oxide delivery systems. Classification determines the regulatory scrutiny and approval process required for each product.

Class III classification applies to devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Nitric oxide delivery systems fall into this category because they directly impact critical respiratory function in neonatal and pediatric patients, requiring rigorous premarket approval to ensure safety and efficacy.