PRO Devices A/S

PRO Devices A/S specializes in Class A medical devices, specifically the PD-100. Class A devices are generally considered low-risk, such as simple dressings or common bandages, and require less stringent regulatory scrutiny than higher-risk categories. The PD-100 is designed for a specific application, though the exact use is not detailed in the provided data.

PRO Devices A/S is headquartered in Denmark (DK). The country of origin can be relevant for regulatory compliance, as it may influence the device’s classification and the applicable regulatory framework, such as EU MDR for devices marketed in the European Union.

Yes, the PD-100 is listed in the EU’s eudamed registry. This database is used to track medical devices placed on the market within the European Economic Area (EEA), ensuring transparency and traceability for regulatory oversight. Listing in eudamed is mandatory for devices marketed in the EU.

The PD-100 falls under Class A classification, which is the lowest risk category for medical devices. This classification is determined by factors like the device’s intended purpose, duration of use, and potential risks to patients. Class A devices typically undergo minimal regulatory scrutiny compared to higher-risk classes (B, C, or D).