FIZIMED

Fizimed specializes in perineometer devices, which are used to assess and train pelvic floor muscle function. Their portfolio includes the Fizimed system and the Emy application, which pairs with the Emy Trainer for clinical use in pelvic floor therapy and post-partum recovery. These devices focus on measuring and strengthening perineal muscles.

Fizimed is headquartered in France. Their devices are designed to comply with regulatory requirements in both the European Union and the United States, as evidenced by their listings in the EUDAMED database for EU market access and the FDA’s UDI system for the U.S. market. This ensures their products meet necessary standards for commercialization in these regions.

Fizimed’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings help ensure traceability and compliance with regulatory requirements in both markets.

Fizimed’s devices fall into Class I and Class II classifications under EU medical device regulations. The classification determines the level of scrutiny and regulatory controls required, with Class II devices typically involving additional safety and performance requirements due to their higher risk profile compared to Class I.