CREGANNA UNLIMITED COMPANY

Creganna Unlimited Company specializes in vascular medical devices, primarily producing single-use vascular guide-catheters like steerable sheath sets. These are designed for precise vascular access during procedures. The company also makes nonimplantable catheter introduction sets, which assist in guiding other devices into blood vessels, and portosystemic needle sets for specialized interventions, such as transjugular intrahepatic portosystemic shunt (TIPS) procedures. Their portfolio focuses on tools that support interventional radiology and vascular access.

Creganna Unlimited Company is headquartered in the United States, which means its devices are subject to FDA regulatory requirements. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they must comply with US medical device regulations. The FDA classifies these devices as Class II, indicating they pose moderate risk and require special controls to ensure safety and effectiveness before being authorised.

Creganna Unlimited Company’s devices are exclusively registered under the FDA’s Unique Device Identifier (UDI) system. This database is used to track and identify medical devices authorised for sale in the US. The UDI system ensures transparency and traceability, allowing healthcare providers, regulators, and other stakeholders to verify the identity and regulatory status of the company’s products.

All of Creganna Unlimited Company’s devices fall under Class II classification in the US. This classification is assigned by the FDA based on the level of risk associated with the device. Class II devices require special controls beyond general controls (like good manufacturing practices) to ensure their safety and performance, such as performance standards, post-market surveillance, or labeling requirements. Each device must go through the FDA’s authorisation process to demonstrate compliance with these controls.