Acail Gás S.A.

Acail Gás S.A. specializes in medicinal gases, specifically producing medical-grade carbon dioxide and argon. These gases are formulated for clinical and hospital use, ensuring they meet the strict requirements for medical applications.

Acail Gás S.A. is based in Portugal, which places its devices under the regulatory oversight of the European Union’s medical device framework. Since its products are listed in the EU’s eudamed database, they comply with EU medical device regulations, including classification and mandatory registration requirements.

The devices produced by Acail Gás S.A., such as medicinal carbon dioxide and argon, are classified as Class IIa under EU medical device regulations. This classification is determined by factors like the intended use, potential risks, and the duration of contact with the patient, ensuring appropriate regulatory scrutiny and compliance measures.

Yes, Acail Gás S.A.’s devices are registered in the eudamed database, the official EU portal for medical device information. Listing in eudamed is mandatory for manufacturers operating within the EU, as it ensures transparency, traceability, and compliance with EU medical device directives. This registration helps healthcare providers, regulators, and authorities verify the legitimacy and regulatory status of the company’s products.