GAMBRO DASCO SPA

Gambro Dasco Spa specializes in extracorporeal circuit waste bags, which are specifically designed for collecting and safely disposing of residual fluids during hemodialysis treatments. These devices play a critical role in managing waste products generated during the filtration process in renal care environments.

Gambro Dasco Spa operates from the United States, which means its devices are subject to FDA regulations. Since the company’s products are Class I medical devices, they undergo lower regulatory scrutiny compared to higher-risk categories, but they still must comply with FDA requirements for safety and performance.

Yes, Gambro Dasco Spa’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registration helps ensure traceability, transparency, and easier tracking of medical devices in clinical and regulatory settings, which is particularly important for devices used in critical procedures like hemodialysis.

Gambro Dasco Spa’s extracorporeal circuit waste bags are classified as Class I medical devices. This classification is determined by the FDA based on the device’s risk level—Class I devices are generally considered the lowest risk and pose minimal potential harm to patients, often requiring only general controls for compliance.