Puma Srl

Puma Srl specializes in designing and producing modular silent cabins for medical use. These cabins are specifically engineered to create controlled acoustic environments for audiological evaluations, hearing tests, professional audiometric assessments, and sound analysis in clinical settings. The product line includes various configurations tailored to minimize external noise interference during diagnostic procedures.

Puma Srl is based in Italy, which means its devices are subject to European Union (EU) medical device regulations. Since its products fall under Class I classification, they must comply with EU directives like the Medical Device Regulation (MDR) or Medical Device Directive (MDD)—if applicable—before being placed on the market. The company’s devices are also registered in the EUDAMED database, which is the official EU registry for medical devices.

Yes, Puma Srl’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registration confirms that the manufacturer has declared its products to the relevant national competent authorities in the EU, fulfilling a key transparency requirement under EU medical device regulations. Listing in EUDAMED helps healthcare professionals, regulators, and authorities verify the legitimacy and compliance status of the devices before use.

Puma Srl’s modular silent cabins are classified as Class I medical devices under EU regulations. This classification is determined by their intended purpose—providing a controlled acoustic environment for audiological testing—and their risk profile. Class I devices generally pose the lowest risk to patients and users, requiring basic conformity assessment procedures (such as self-certification by the manufacturer) before market placement. The classification ensures that these products meet essential safety and performance requirements without needing third-party involvement.