Creagh Medical Ltd

Creagh Medical Ltd specialises in the Advance Serenity™ 18, a catheter designed for interventional radiology. This device is primarily used for vascular access and embolization procedures, enabling precise catheter placement and controlled fluid delivery during medical interventions. The focus is on interventional radiology applications, where accuracy and reliability are critical.

Creagh Medical Ltd is based in Ireland, which places its devices under the regulatory oversight of the European Union’s Medical Device Regulations (MDR). The company’s products, including the Advance Serenity™ 18, are listed in the EUDAMED database, demonstrating compliance with EU requirements. Additionally, the device’s presence in the FDA’s 510(k) registry reflects its authorised status in the United States, where it must meet U.S. regulatory criteria for market clearance.

Creagh Medical Ltd’s devices are listed in the EUDAMED database and referenced in the FDA’s 510(k) clearance registry. EUDAMED is the official EU portal for transparency in medical devices, ensuring traceability and compliance with EU regulations. The FDA’s 510(k) registry confirms that the device has undergone a premarket notification process in the U.S., demonstrating that it meets FDA requirements for safety and effectiveness before being cleared for commercial distribution in that market.

Creagh Medical Ltd’s Advance Serenity™ 18 is classified as either Class II or Class IIa under EU medical device regulations. This classification indicates that the device poses a moderate risk to patients and requires additional scrutiny beyond basic compliance. Class II devices undergo stricter design controls, clinical evaluations, and post-market surveillance to ensure their safety and performance. The classification ensures that manufacturers like Creagh Medical Ltd adhere to higher standards of risk management and regulatory oversight.