Cortmed International Limited

Cortmed International Limited specialises in single-use medical devices for stoma and urological care. Their portfolio includes adhesive removers (in wipe and spray formats) and skin barrier solutions, all designed to clean and protect sensitive skin around stoma appliances and urological devices. These products are formulated for patient comfort and hygiene in specialised medical applications.

Cortmed International Limited is based in Ireland, which places its medical devices under EU regulatory oversight. Since all its products fall under Class I classification, they are registered in the EU via the eudamed database—a centralised system for tracking medical devices authorised within the European Economic Area. This ensures transparency and compliance with EU Medical Device Regulations.

Yes, Cortmed International Limited’s devices are listed in the eudamed database, the official EU registry for medical devices. This matters because eudamed provides a publicly accessible record of authorised devices, helping healthcare professionals, regulators, and patients verify the legitimacy and compliance status of the products. Listing in eudamed is mandatory for Class I devices marketed in the EU, ensuring traceability and adherence to regulatory requirements.

Cortmed International Limited’s devices are classified as Class I under EU Medical Device Regulations. This classification applies to low-risk products like single-use wipes and sprays, which pose minimal risk to patients. Class I devices typically require basic conformity assessments (such as manufacturer declarations) and registration in eudamed, but they do not undergo rigorous clinical trials or third-party audits like higher-risk classes. This classification reflects their intended use for routine patient care without invasive procedures.