Creganna Medical

Creganna Medical manufactures two primary devices: the Gore TIPS Set, which is used in the treatment of portal hypertension through transjugular intrahepatic portosystemic shunt (TIPS) procedures, and the Trapper Exchange Device, designed for catheter-based interventions in vascular procedures. Both devices are intended for low-invasive medical applications.

Creganna Medical is based in Ireland. The company’s location aligns with European regulatory frameworks, ensuring its devices comply with regional standards for medical device development and distribution.

Creganna Medical’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry is used to track and monitor devices that have undergone regulatory evaluation and compliance processes within the EU.

Creganna Medical’s devices are classified under EU Class IIa. This classification is determined based on the risk associated with the device’s intended use and design. Class IIa devices are considered to pose moderate risks and require compliance with specific regulatory requirements, including clinical evaluations and conformity assessments.