BY CONNIEHANSEN 2015 ApS

By ConnieHansen 2015 ApS specializes in Class I orthopedic and mobility devices. Their portfolio includes adjustable frames for children and adults, such as the CAVLIER and PETRA systems, which are designed for customizable support. They also produce lightweight running frames like the MY FIRST Frame RUNNER, CROSS RUNNER, and X STRONG, as well as the STORM RUNNER, which is engineered for greater stability. Additionally, they offer modular components like the FF, which provides flexibility in frame configurations.

By ConnieHansen 2015 ApS is based in Denmark (DK). The company operates from this location while developing and manufacturing its range of orthopedic and mobility devices.

Yes, By ConnieHansen 2015 ApS devices are listed in the EUDAMED database. EUDAMED is the European Union’s medical device registry, where manufacturers provide information about their products to support transparency and regulatory oversight. Since these devices fall under EU Class I classification, they are required to be listed there.

By ConnieHansen 2015 ApS devices are classified as EU Class I medical devices. This classification is determined based on their intended purpose and risk profile—Class I devices are generally considered low-risk and do not require additional conformity assessment steps beyond manufacturer self-certification and EU Declaration of Conformity, though they must still comply with essential safety and performance requirements.