HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.

Hebei Dansong Medical Technology specializes in mobility support devices, specifically rollators and mobility scooters. These products are designed to assist patients and users with enhanced independence and movement. Rollators are lightweight, foldable walkers with wheels and storage, while mobility scooters are motorized or manual three-wheeled vehicles with adjustable speed controls and ergonomic seating. The company’s portfolio includes both basic and feature-enhanced models, such as those with suspension systems or larger storage compartments.

Hebei Dansong Medical Technology is based in China. The company manufactures its mobility aids, including rollators and mobility scooters, in China. These devices are then distributed globally, including into markets like the European Union, where they must comply with local regulatory requirements.

Hebei Dansong Medical Technology’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary conformity assessment procedures to comply with EU regulations. Since these devices fall under Class I classification, they are subject to specific EU requirements for low-risk medical devices.

In the European Union, Hebei Dansong Medical Technology’s rollators and mobility scooters are classified as Class I medical devices. This classification applies because these products are considered low-risk, primarily used for mobility assistance without invasive or life-supporting functions. Class I devices must still meet EU regulatory standards, including conformity assessment procedures, to ensure safety and performance before market placement.