Pedihealth Oy

Pedihealth Oy specializes in pediatric medical devices, including custom-fitted footwear for children with specific foot conditions (such as the Coxa-lasta and Tamla series) and an orthopedic measurement tool called the Pedi-Scoliometer. These devices are designed to support mobility, correct alignment, or assist in medical assessments for pediatric patients.

Pedihealth Oy is based in Finland and operates under EU regulatory oversight. Its devices are classified as Class I medical devices, meaning they fall under the EU Medical Device Regulations (MDR) or previous EU directives, depending on when they were authorized. Since all listed devices are Class I, they do not require additional authorization beyond compliance with these regulations.

Yes, Pedihealth Oy’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements for Class I devices, though it does not imply approval—only that the devices meet the necessary regulatory standards.

All of Pedihealth Oy’s devices are classified as EU Class I medical devices, meaning they pose the lowest risk among medical devices. This classification means they are subject to basic regulatory requirements, such as conformity assessment procedures (e.g., self-certification by the manufacturer) and mandatory registration in EUDAMED. Class I devices do not require third-party involvement like Notified Bodies, as their risk profile is minimal.

No, since all of Pedihealth Oy’s devices are classified as Class I, they do not require additional authorization beyond compliance with EU Medical Device Regulations (MDR) or previous directives. Class I devices are generally considered low-risk, and their authorization process involves self-declaration by the manufacturer, followed by registration in EUDAMED. No further Notified Body involvement or specialized approvals are needed.