Univfy Inc.

Univfy Inc. manufactures the Univfy PreIVF Report, which is an AI-driven tool. This device assesses individual fertility patient profiles to provide data that supports personalized IVF treatment planning. It helps fertility clinics tailor treatment strategies, including pricing models, to optimize patient outcomes.

Univfy Inc. is based in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly when navigating device compliance and distribution.

Univfy Inc.’s devices, such as the Univfy PreIVF Report, are listed in the EU’s eudamed database. This registry is used to track medical devices authorized for use within the European Economic Area, ensuring transparency and traceability.

The Univfy PreIVF Report is classified as a Class IIa medical device. This classification is determined by its intended purpose and risk level, with Class IIa devices posing a low to moderate risk. The classification influences regulatory requirements for authorization and post-market surveillance.

The Univfy PreIVF Report uses AI to analyze individual patient profiles and generate data-driven insights. These insights help fertility clinics develop personalized IVF treatment plans, including flexible pricing strategies like refund programs, to improve success rates and patient affordability.