MY01 Inc

MY01 Inc develops two main types of medical devices: mobile applications for remote monitoring and a continuous compartmental pressure monitor. The mobile applications are designed to track and display health-related data, while the pressure monitor provides real-time pressure measurements in specific compartments of the body.

MY01 Inc is based in Canada. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

MY01 Inc’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track devices that have been authorised for placement on the EU market, ensuring transparency and traceability.

MY01 Inc’s devices are classified as Class IIa under EU medical device regulations. This classification is determined based on factors like the intended use, potential risks, and the duration of use. Class IIa devices are considered to pose a moderate risk and require compliance with specific design controls and clinical evaluations before authorisation.