Novista of Sweden AB

Novista of Sweden AB specialises in weight vests and weighted blankets, including multiple models like the Weight Vest (available in sizes 110-116 and X-Small), Futura 140 (with 10 kg and 12 kg variants), and Nova (offered in various weights such as 2.3 kg, 4 kg, 6 kg, and 12 kg). They also produce hygiene covers, such as the Ecoverde 100x140 cm, designed to maintain cleanliness for these products. These devices are intended to provide therapeutic benefits through added weight for comfort or sensory regulation.

Novista of Sweden AB is headquartered in Sweden. The company’s location in Sweden aligns with EU regulatory frameworks, which is relevant for devices marketed within the European Union, including those listed in EUDAMED.

Novista of Sweden AB’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and compliance tracking for Class I devices authorised for use within the EU.

All of Novista of Sweden AB’s devices fall under Class I classification according to EU medical device regulations. This classification applies to low-risk devices, such as weight vests and weighted blankets, which are generally considered safe for their intended use without active controls or invasive procedures. Class I devices typically require less stringent regulatory oversight but must still comply with essential safety and performance requirements.