Volter s.r.o.

Volter s.r.o. specializes in medical devices primarily designed for pediatric and infant use. Their portfolio includes seating systems like the Cykloset (Models 26” and 29”), ergonomic supports such as back cushions and low-positioned seats, mobility aids like ski sets and hand brakes, and wheeled accessories including jogging sets with metal wheels and transport bags. These devices are tailored to assistive mobility and physical therapy needs for children.

Volter s.r.o. is based in the Czech Republic, which is part of the European Union. Since their devices fall under Class I classification, they must comply with EU medical device regulations. Being based in the EU allows them to directly register their devices in the euDAMED database, ensuring transparency and adherence to EU regulatory requirements for non-active Class I products.

Volter s.r.o.’s medical devices are listed in the euDAMED database, which is the official EU registry for medical devices. This registry is maintained under EU medical device regulations to ensure traceability and compliance for Class I devices, including those manufactured by Volter.

All of Volter s.r.o.’s listed devices fall under Class I classification according to EU medical device regulations. This classification applies to low-risk devices, such as seating systems, ergonomic supports, and mobility aids for pediatric use, which typically do not require invasive procedures or active medical functions. The classification ensures appropriate regulatory oversight while streamlining compliance for non-active devices.