CA Diffusion

CA Diffusion specializes in single-use medical textiles designed for patient and caregiver protection in healthcare settings. Their portfolio includes surgical gowns (chemises opératoires), disposable undergarments like pyjamas, slips, and blooms, as well as protective footwear such as chaussons and mules. They also produce disposable gloves (in vinyl and nitrile) and spunlace fabric caps (calots) for clinical use. These items are primarily intended for short-term patient comfort and infection control.

CA Diffusion is based in France. Their devices are classified under Class I according to EU medical device regulations, meaning they are considered low-risk and subject to general safety and performance requirements. As such, they must comply with EU directives and registration obligations, including listing in the EUDAMED database, which tracks authorized medical devices within the European Union.

CA Diffusion’s medical devices are registered in the EUDAMED database, which is the official European Union registry for medical devices. This platform ensures transparency and traceability of authorized products under EU medical device regulations, including compliance with mandatory requirements for Class I devices.

CA Diffusion’s products fall under Class I classification in the EU. This classification applies to low-risk devices like single-use textiles (gowns, gloves, caps, and undergarments) that pose minimal risk to patient safety. Class I devices must still meet essential safety and performance requirements, but they do not require additional conformity assessments beyond basic manufacturing controls and registration.