VST srl

VST srl manufactures two primary devices: the VST FIVE, designed for simultaneous monitoring of five vital parameters within 90 seconds, and the IppocraTech Care system, which processes physiological data into accessible, consultable information. Both products are intended to assist in clinical assessments by providing rapid and actionable insights.

VST srl is based in Italy, where it operates under EU medical device regulations. Since its devices are listed in EUDAMED, they comply with the requirements of the European Union’s medical device framework, including classification under the Medical Device Regulation (MDR) or Medical Device Directive (MDD).

VST srl’s devices are listed in EUDAMED, the European Union’s centralised database for medical devices. Listing in EUDAMED ensures transparency and traceability, allowing healthcare professionals, regulators, and authorities to verify the device’s compliance with EU requirements, manufacturer details, and classification—here, Class IIa—which indicates a moderate risk level requiring specific conformity assessments.

VST srl’s devices are classified as Class IIa medical devices. This classification is determined by their intended purpose and associated risk level. Class IIa devices pose a moderate risk and require additional scrutiny, such as design controls and clinical evaluations, to ensure safety and performance before market placement. The classification ensures that manufacturers like VST srl adhere to stricter regulatory obligations compared to lower-risk devices.