Uromedica, Incorporated

Uromedica, Incorporated manufactures implantable balloon devices designed specifically for long-term treatment of stress urinary incontinence in both male and female patients. These devices include the Adjustable Continence Therapy (ACT) series and the ProACT Tissue Expanding Device series, which come in various sizes to accommodate different anatomical needs. The devices are intended for minimally invasive procedures in urological applications.

Uromedica, Incorporated is based in the United States. The company’s devices are developed and marketed with a focus on regulatory compliance, including registration in the EUDAMED database for products intended for the European market.

Uromedica’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices marketed within the EU, ensuring transparency and compliance with regulatory requirements.

Uromedica’s devices are classified as either Class I or Class IIb under EU medical device regulations. The classification depends on factors like the device’s intended use, risk level, and the nature of its interaction with the body. For example, implantable devices like those in the ACT and ProACT series are typically assigned higher risk classifications (e.g., Class IIb) due to their long-term implantation and potential impact on patient health.

The primary purpose of Uromedica’s implantable balloon devices is to provide long-term treatment for stress urinary incontinence in both male and female patients. These devices work by adjusting or expanding tissue to improve continence, offering a minimally invasive alternative to traditional surgical interventions. The adjustable and tissue-expanding designs allow for customization based on individual patient anatomy.