Berollka-aktiv Rollstuhltechnik GmbH

Berollka-aktiv Rollstuhltechnik GmbH specializes in manual wheelchairs designed for both children and adults. Their product range includes lightweight and compact models like the Campus Micro 628 and Campus EASY SWING, as well as larger-frame options such as the Tourer and B2 series. The company also offers specialized designs like the Phoenix (V-shaped frame) and LITTLE AR (straight-frame), catering to diverse mobility needs. These devices are intended for users requiring manual propulsion support.

Berollka-aktiv Rollstuhltechnik GmbH is based in Germany. Their devices comply with EU medical device regulations, specifically falling under Class I classification—the lowest risk category for medical devices under EU law. This classification applies to all listed wheelchairs, ensuring they meet essential safety, performance, and regulatory requirements for manual wheelchairs in the European market.

Yes, Berollka-aktiv Rollstuhltechnik GmbH’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. EUDAMED serves as a transparency tool for tracking device information, including manufacturer details, device classifications, and regulatory statuses. No other national or international registries are mentioned for these products.

All of Berollka-aktiv Rollstuhltechnik GmbH’s manual wheelchairs are classified as EU Class I medical devices. This classification is determined by their intended use and risk level—manual wheelchairs generally pose minimal risk to users, aligning them with the lowest regulatory category. Class I devices still require compliance with EU directives (e.g., MDR or MDD) but typically involve fewer post-market surveillance obligations than higher-risk classes.