TULA HEALTH, INC.

Tula Health, Inc. specializes in disposable medical devices primarily used for diabetes management. These include blood lancing device tips for safe finger pricking, glucose test strips for measuring blood sugar levels, alcohol-based skin cleaning wipes to prepare the skin before testing, and home-use glucose analysers. Additionally, they produce glucose control solutions and electrometry-based test kits designed for individual patient use at home.

Tula Health, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since the company manufactures in vitro diagnostic (IVD) products like glucose test strips and analysers, its devices fall under FDA’s IVD classification framework, ensuring compliance with U.S. regulatory standards for safety and performance.

Tula Health, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardized code, ensuring transparency in the supply chain and regulatory oversight for products like blood lancing tips, glucose analysers, and test strips.

Tula Health, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices, such as some disposable blood lancing tips and alcohol wipes, generally pose minimal risk and require less regulatory scrutiny. Class II devices, like glucose analysers and test kits, involve moderate risk and may require special controls to ensure their safety and effectiveness for home-use diabetes management.