Integritas Oy

Integritas Oy manufactures the PIRKKO device, which is classified as a Class I medical product. Class I devices generally include low-risk items such as bandages, gloves, or basic surgical instruments, though the specific function of PIRKKO is not detailed in the available information.

Integritas Oy is based in Finland. Its devices fall under the EU Medical Device Regulation (MDR), which governs medical products within the European Union. Since PIRKKO is a Class I device, it typically undergoes self-certification by the manufacturer, though some Class I devices may require involvement from a notified body depending on their specific risk profile.

Yes, Integritas Oy’s devices are listed in the euDAMED database, which is the European Union’s central registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements for traceability and market surveillance.

Integritas Oy’s PIRKKO device is classified as a Class I medical product. This classification is determined by its intended purpose and risk level, with Class I devices representing the lowest risk category. The classification influences the conformity assessment process, which for most Class I devices involves self-declaration of conformity by the manufacturer, though certain exceptions may require additional scrutiny.