Funktionsverket AB

Funktionsverket AB produces devices primarily focused on supporting cognitive and communication needs. Their product line includes the Timstock, which appears to serve multiple purposes such as governance, assembly, and cognitive assistance, as well as the WidgitPlattan, a communication aid designed for individuals with speech or cognitive challenges. These devices are tailored for users with conditions like autism, ADHD, or dementia, as well as educational and elderly care environments.

Funktionsverket AB is based in Sweden, as indicated by its country designation. The company’s location is relevant for understanding its regulatory context and market focus within the European Union.

Yes, Funktionsverket AB’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This listing is required under the EU Medical Device Regulation (MDR) to ensure transparency and traceability of devices marketed within the European Economic Area.

Funktionsverket AB’s devices fall under Class I classification according to the EU Medical Device Regulation. This classification is typically assigned to low-risk devices that pose minimal risk to patients and users, such as certain aids for communication or cognitive support. The classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.