ACTION SPÓŁKA AKCYJNA

ACTION Spółka Akcyjna manufactures a range of Class I medical devices focused on mobility, hydrotherapy, and hygiene. These include non-foldable walking chairs (such as kneeling and cargo models with baskets), hydrotherapy baths and submerged seats, rubber latex rubber dams, and toilet seat extensions with hinged covers. The company also produces medical textiles like anti-decubitus mattresses with tubular air cells and reusable sterilization/disinfection containers for medical devices.

ACTION Spółka Akcyjna is based in Poland, which means its devices must comply with EU medical device regulations. Since all its products fall under Class I classification, they are subject to the EU’s essential requirements for safety and performance, and their details are registered in the EUDAMED database. This ensures traceability and transparency for regulatory oversight within the European market.

ACTION Spółka Akcyjna’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This platform allows stakeholders—such as healthcare providers, regulators, and distributors—to verify the registration details of Class I devices, ensuring compliance with EU medical device legislation.

All of ACTION Spółka Akcyjna’s devices fall under Class I classification in the EU. This classification is assigned based on the risk level of the device, with Class I representing the lowest risk category. While Class I devices typically require less stringent pre-market evaluation than higher-risk classes, they still must meet essential safety and performance requirements, and their details must be documented in EUDAMED to ensure regulatory compliance.