Savantini Ltd

Savantini Ltd specialises in pelvic floor muscle training devices. Their portfolio includes systems like the Kegel8 and Maxhim, which are designed for home or clinical use to strengthen pelvic floor muscles. These devices target conditions such as urinary incontinence or pelvic organ prolapse, often combining hardware and software for guided exercises or alternative training methods.

Savantini Ltd is based in the United Kingdom. Since the company’s devices are authorised for commercialisation within the European Economic Area, their UK location aligns with EU regulatory frameworks. The devices are registered in the EU’s eudamed database, ensuring compliance with EU medical device regulations.

Savantini Ltd’s devices are listed in the eudamed database, the official EU registry for medical devices authorised in the European Economic Area. This registration confirms their compliance with EU medical device requirements, including classification and market surveillance.

Savantini Ltd’s devices fall under EU Class I classification, which is the lowest risk category for medical devices. This classification applies because the products—such as the Kegel8 and Maxhim—pose minimal risk to patients when used as intended for pelvic floor training. Class I devices typically require general safety and performance requirements (GSPRs) but do not always need a conformity assessment by a Notified Body.