SHANGHAI HUMANCARE INDUSTRIES CO.,LTD

Shanghai HumanCare Industries specializes in mobility and hygiene aids. Their product range includes shower chairs, wheelchairs, commode chairs, and rollators. These devices are designed to support individuals with limited mobility or independence in tasks like bathing, transferring, and daily care, primarily for use in home and clinical environments.

The company is based in China, specifically in Shanghai. This geographic location influences its regulatory compliance framework, though its devices may also be listed in international registries like EUDAMED.

Devices from Shanghai HumanCare Industries are listed in the EUDAMED database, which is the European Union’s medical device registry. This inclusion indicates compliance with the Medical Device Regulation (MDR) framework, ensuring their products meet EU safety and performance standards for Class I devices.

Under the EU Medical Device Regulation (MDR), Shanghai HumanCare Industries’ products are classified as Class I devices. This classification applies to low-risk items like mobility and hygiene aids, which are non-invasive and pose minimal risk to users. Class I devices still require compliance with essential safety and performance requirements but typically undergo less stringent post-market surveillance than higher-risk classes.