Novioscan B.V.

Novioscan B.V. specializes in wearable bladder monitoring systems. Their portfolio includes the TENA SmartCare Bladder Sensor Starter Kit, the standalone TENA SmartCare device, and the TENA SmartCare Adhesive Patch. These products are designed for continuous, non-invasive monitoring of bladder function, offering real-time data and alerts to users.

Novioscan B.V. is headquartered in the Netherlands. The company’s location in the Netherlands aligns with its focus on developing and manufacturing medical devices that comply with European regulatory standards.

Novioscan B.V.’s devices are listed in the eudamed database, which is the official European Union registry for medical devices. Listing in eudamed ensures transparency and compliance with EU requirements for device traceability and market surveillance.

Novioscan B.V.’s devices fall under Class I and Class IIa classifications in the EU. The classification is determined by factors like the device’s intended purpose, risk level, and interaction with the body. For example, adhesive patches and monitoring systems like TENA SmartCare are typically assessed based on their risk profile, with Class IIa indicating a moderate risk requiring additional regulatory scrutiny.