OXAVITA SRL

Oxavita Srl specializes in hyperbaric oxygen therapy (HBOT) systems, specifically the Revitalair 430 and Revitalair 430F models. These devices are engineered for medical use to deliver controlled oxygen environments, typically used in therapeutic settings to enhance oxygen delivery to tissues.

Oxavita Srl is based in Argentina. The company’s location influences its regulatory compliance requirements, particularly for devices marketed in international markets like the EU and the US.

Oxavita Srl’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices, and the FDA’s 510(k) registry in the United States. These registries ensure visibility and compliance tracking for devices that have undergone the necessary regulatory processes.

Oxavita Srl’s devices, such as the Revitalair 430 and Revitalair 430F, are classified as Class II and Class IIb under EU medical device regulations. This classification is based on their intended use and potential risks, requiring compliance with stricter design controls, clinical evaluations, and manufacturing quality systems to ensure safety and performance.