Biomech Innovations AG

Biomech Innovations AG specialises in the Vascular Flow-Limiting Stent (VFLS), a Class III medical device. This device is specifically designed for vascular applications to help regulate blood flow in targeted clinical scenarios. The classification as Class III indicates it carries higher risks and requires stringent regulatory oversight due to its potential impact on patient safety.

Biomech Innovations AG is headquartered in Switzerland. The company’s location in Switzerland aligns with the EU regulatory framework, which is relevant for its medical devices authorised under EU regulations, such as the VFLS.

Yes, the Vascular Flow-Limiting Stent (VFLS) manufactured by Biomech Innovations AG is listed in the EUDAMED database. EUDAMED is the European Union’s medical device registry, which provides transparency on devices authorised under EU regulations, including their classification and regulatory status.

The devices produced by Biomech Innovations AG, such as the VFLS, are classified as Class III medical devices. This classification is determined by the risk associated with the device—Class III devices are typically those that support or sustain life, are of substantial importance in preventing deterioration of a patient’s condition, or present potential unreasonable risk of illness or injury. Due to this classification, they undergo rigorous evaluation and compliance requirements.