Harpo sp. z o.o.

Harpo sp. z o.o. manufactures the Exesystem, a medical device designed to assist individuals with disabilities, blindness, or those needing specialized treatment support. The device appears to be a reusable system aimed at improving mobility, accessibility, or adaptive functionality in various settings.

Harpo sp. z o.o. is based in Poland. Since its devices are classified as Class I under EU regulations, they must comply with the relevant EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. This classification means they pose minimal risk, but they still require adherence to EU regulatory standards for market placement.

Yes, Harpo sp. z o.o.’s devices are listed in the EU’s eudamed registry, which is the official database for medical devices within the European Economic Area. Listing in eudamed is required for manufacturers to demonstrate compliance with EU regulatory obligations and to provide transparency to authorities and healthcare professionals.

Harpo sp. z o.o.’s Exesystem is classified as a Class I medical device under EU regulations. This classification is determined based on the device’s intended purpose and risk level—Class I devices are generally considered low-risk, such as simple accessories or devices with minimal contact to the body. Classification ensures appropriate regulatory oversight while streamlining compliance requirements.