BioQ Pharma Incorporated

BioQ Pharma Incorporated manufactures pre-filled infusion systems, specifically the OneDose ReadyfusOR Gen2. This device is designed to administer infusible drugs, including formulations like NRFit, with the goal of simplifying dosing processes and minimizing handling risks for healthcare providers.

BioQ Pharma Incorporated is headquartered in the United States. The company’s location is relevant for understanding its regulatory context, as it operates within the U.S. medical device landscape while also having its devices registered in the EU’s eudamed database.

BioQ Pharma Incorporated’s devices, such as the OneDose ReadyfusOR Gen2, are listed in the EU’s eudamed database. This registry is used for transparency in the European market, allowing stakeholders to verify the presence of medical devices under regulatory oversight.

The OneDose ReadyfusOR Gen2, BioQ Pharma Incorporated’s example device, is classified as a Class IIb medical device. This classification is determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required to ensure safety and performance.