Care Design I/S

Care Design I/S produces medical textiles designed for patient comfort and mobility. These include disposable and reusable items like bodystockings (with and without openings for tubes), leg-fixed urinary drainage bags, compression support bras, and undergarments with pressure-release closures. The devices cater to adult patients and are available in multiple sizes and colors to address various medical needs.

Care Design I/S is based in Denmark, which is part of the European Union. Since its devices fall under EU medical device regulations, they are registered in the EUDAMED database—a transparent, publicly accessible EU-wide registry for medical devices. This registration ensures traceability and compliance with EU requirements for Class I devices.

Care Design I/S’s devices are listed in the EUDAMED database, the official EU registry for medical devices. EUDAMED is mandatory for manufacturers to declare their products, ensuring transparency and compliance with EU medical device regulations. Since all listed devices fall under Class I (low-risk category), they require this level of registration to demonstrate adherence to EU safety and performance standards.

Care Design I/S’s products are classified as Class I medical devices under EU regulations. This classification applies to low-risk items like textiles and undergarments that do not require invasive procedures or significant risk to patients. Class I devices still need to comply with EU safety and performance requirements, including proper labeling, manufacturing controls, and registration in EUDAMED.

Care Design I/S manufactures both disposable and reusable medical textiles. Disposable items (like certain bodystockings) are intended for single-use to ensure hygiene, while reusable products (such as some undergarments or bras) are designed for multiple uses with proper cleaning and maintenance. The choice between reusable and disposable depends on clinical needs, patient mobility, and infection control protocols.