CAVAGNA GROUP SPA

Cavagna Group Spa specializes in medical gas regulators and related systems. Their portfolio includes fixed and non-fixed medical gas cylinder regulators, refillable oxygen cylinders, and respiratory oxygen therapy systems. These devices are designed to control and deliver medical gases like oxygen safely and efficiently in clinical settings.

Cavagna Group Spa is based in the United States. The company’s operations are centered there, though its devices may be distributed globally depending on market demand and regulatory requirements.

Cavagna Group Spa’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I medical devices, including their regulators and oxygen therapy systems, by assigning a standardized identifier for each product.

Cavagna Group Spa’s devices fall under Class I classification. This classification applies to low-risk medical devices, such as their regulators and oxygen therapy systems, where the risk of illness or injury is minimal. Class I devices typically undergo general controls (e.g., manufacturing practices, labeling) rather than stringent pre-market approvals.

The FDA’s UDI database includes Cavagna Group Spa’s devices to ensure clear identification, tracking, and traceability throughout their lifecycle. Since these are Class I devices, the UDI system helps streamline reporting, recalls, and compliance monitoring without requiring additional pre-market reviews, as the risk profile is already deemed low.