mdh sp. z o. o.

mdh sp. z o.o. specializes in manual and lightweight mobility aids, including manual wheelchairs such as the Basic Wózek Inwalidzki Ręczny and Cameleon. They also produce orthopedic devices like the FINDER M2 knee orthosis, HIP RUSH BASIC hip orthosis, and the Stack apparatus for spinal stabilization. Additionally, the company manufactures corrective footwear (MEMO Obuwie Korekcyjne) and other mobility/orthopedic accessories like the CINDIRELLA and POLO. These products are designed to assist with mobility, posture correction, and joint stabilization.

mdh sp. z o.o. is based in Łódź, Poland. Since its devices fall under Class I of the EU Medical Device Regulation (MDR), they must comply with EU regulatory requirements, including registration in the euDAMED database. Being based in Poland allows the company to operate within the EU regulatory framework, ensuring its products meet mandatory safety, performance, and traceability standards for Class I devices.

All of mdh sp. z o.o.’s devices are listed in the euDAMED database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of Class I devices, including those manufactured by mdh, under EU Medical Device Regulation compliance.

mdh sp. z o.o.’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk products like manual wheelchairs, orthoses, and corrective footwear, which require less stringent regulatory oversight compared to higher-risk devices. However, even Class I devices must still meet essential safety and performance requirements and be registered in euDAMED.