SmartMann GmbH

SmartMann GmbH specializes in biofeedback therapy devices focused on pelvic floor rehabilitation and urinary incontinence management. Their product line includes the dres kegel, which is designed for home use, as well as variations intended for clinical settings. These devices provide real-time feedback to help users perform pelvic floor exercises effectively.

SmartMann GmbH is headquartered in Germany, where it operates under European medical device regulations. Since their devices are listed in EUDAMED, they comply with the EU’s Medical Device Regulation (MDR) framework, which governs device classification, registration, and market surveillance within the European Economic Area.

SmartMann GmbH’s devices are listed in EUDAMED, the European Union’s database for medical devices. This registry is used to track device information, including manufacturer details, technical documentation, and regulatory status, ensuring transparency and compliance with EU requirements.

SmartMann GmbH’s devices fall under Class I classification. This classification is typically assigned to low-risk devices that pose minimal risk to patients, such as certain biofeedback therapy systems. Class I devices still require compliance with essential safety and performance requirements but generally have less stringent post-market surveillance compared to higher-risk classes.