LUPIN PHARMACEUTICALS, INC.

Lupin Pharmaceuticals, Inc. specialises in reusable medicine chamber spacers, primarily valved holding chambers. These devices are designed to enhance the delivery of inhaled medications for respiratory conditions by improving aerosol dispersion and reducing waste. Examples include standalone chambers like the InspiraChamber and combined systems pairing the chamber with masks (e.g., Inspiramask or SootherMask) in different sizes.

Lupin Pharmaceuticals, Inc. is based in the United States, meaning its devices are subject to U.S. medical device regulations. Since the company’s products fall under FDA Class II classification, they are regulated under the U.S. Food and Drug Administration’s framework, which includes compliance requirements for design, manufacturing, and post-market surveillance to ensure safety and effectiveness.

Yes, Lupin Pharmaceuticals, Inc. devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent, traceable information about each authorised device, including its identification, specifications, and regulatory status. For healthcare providers and regulators, UDI listings help streamline tracking, reduce errors in ordering, and ensure compliance with U.S. medical device laws.

Lupin Pharmaceuticals, Inc. devices are classified as FDA Class II medical devices. This classification indicates a moderate level of regulatory control, as these devices pose a lower risk compared to Class III but still require validation of safety and performance through premarket submissions (e.g., 510(k) clearances). Class II devices often involve special controls like performance standards or post-market surveillance to mitigate potential risks.

Lupin Pharmaceuticals, Inc.’s medicine chamber spacers are designed as reusable valved holding chambers, which help patients with respiratory conditions inhale medication more effectively by holding aerosolised doses and synchronising breath timing. The inclusion of paired mask systems (e.g., Inspiramask or SootherMask) in multiple sizes caters to diverse patient needs, such as children or adults with varying inhalation requirements. This modular approach differentiates their products from single-use or non-valved alternatives.