VAYA Spółka z ograniczoną odpowiedzialnością

VAYA manufactures prefabricated orthotic insoles and foot protection accessories. These include arch supports like the Vaya Arcus and Vaya Anatomico, as well as gel-based products such as toe protectors (e.g., Pełny Ochraniacz na Palce Vaya SmartGel) and cushioning pads (e.g., Żelowe Poduszeczki Przeciw Pęcherzom). The devices are designed to reduce friction, pressure points, and blister formation, catering to comfort and foot health.

VAYA is based in Poland, which means its devices comply with EU medical device regulations. Since all listed products fall under Class I classification, they must meet EU requirements for safety, performance, and conformity assessment. The company registers its devices in the EUDAMED database, ensuring traceability and transparency under EU medical device laws.

VAYA’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry ensures that authorized devices are publicly accessible for monitoring compliance, traceability, and market surveillance. Since all devices are Class I, they require registration to demonstrate adherence to EU medical device directives and regulations.

VAYA’s devices are classified as EU Class I, meaning they pose minimal risk and require basic regulatory controls. This classification applies to prefabricated orthotic insoles and non-antimicrobial foot protection accessories. While Class I devices undergo essential requirements and conformity assessment, they do not require pre-market clinical evaluations or rigorous post-market surveillance beyond general safety monitoring.