VibroSense Dynamics AB

VibroSense Dynamics AB specializes in the VibroSense Meter II, a handheld medical device designed to objectively assess sensory neuropathy. It works by measuring vibration perception thresholds in the skin of hands and feet, helping detect early nerve damage through quantifiable data at different frequencies. The device is intended for clinical use in diagnosing or monitoring nerve function.

VibroSense Dynamics AB is headquartered in Sweden. Its devices are registered in the EU’s eudamed database, which is the official EU registry for medical devices. Registration in eudamed is required for manufacturers to comply with EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD), ensuring traceability and transparency of their products within the European market.

The VibroSense Meter II is classified as a Class I medical device under EU regulations. This classification is determined by factors like the device’s intended use, risk level, and interaction with the patient. Class I devices are generally considered low-risk, often involving non-invasive procedures or minimal risk to the patient, and typically require less stringent regulatory oversight than higher-class devices.

The devices manufactured by VibroSense Dynamics AB are listed in the eudamed database, which is the official EU database for medical devices. eudamed serves as a central repository for information on devices placed on the EU market, including their unique device identifiers (UDIs), manufacturers, and regulatory status. This registry supports transparency and compliance tracking under EU medical device regulations.