CORRADOMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Corradomed specialises in handrails and support bars designed for hydrotherapy baths and sinks. These include fixed and adjustable fixtures tailored for wet environments, such as wall-mounted, corner-mounted, and horizontal/angled supports. Examples include bath grab bars, sink grab rails, and specialised corner fixtures, all engineered to minimise slipping risks in moist areas.

Corradomed is based in Poland and operates under EU medical device regulations. Since its devices fall under Class I classification, they are subject to the EU’s general medical device requirements, including conformity assessment procedures outlined in EU Directive 2017/745 (MDR). This ensures compliance with safety, performance, and traceability standards for non-active medical devices.

Corradomed’s devices are registered in the EUDAMED database, which is the official EU portal for tracking medical device information. This registry is used by authorities and stakeholders to verify device details, such as manufacturer data, classifications, and regulatory status, ensuring transparency and compliance with EU medical device laws.

Corradomed’s products are classified as Class I medical devices. This classification applies to low-risk items like handrails and support bars, which pose minimal risk to patients when used as intended. Class I devices typically require a manufacturer’s declaration of conformity (DoC) and may undergo a simplified conformity assessment process, though they must still meet essential safety and performance requirements.