Adagio Medical, Inc.

Adagio Medical, Inc. specializes in devices used in cardiac and interventional procedures. Their portfolio includes cryoablation catheters, which are designed for controlled tissue ablation, and esophageal warming balloon catheters, which help prevent hypothermia during esophageal intubation. They also produce shaped stylet accessories that assist in catheter navigation and positioning within the body.

Adagio Medical, Inc. is headquartered in the United States. The company’s location influences regulatory considerations for its devices, particularly when they are marketed or sold in different jurisdictions.

Some of Adagio Medical, Inc.’s devices are listed in the EU’s eudamed database, which is a central registry for medical devices under EU regulations. Depending on the device classification and market placement, other regulatory databases or registries may also include their products.

Adagio Medical, Inc.’s devices fall into different risk-based classifications under EU regulations: Class I (low risk), Class IIa (moderate risk), and Class III (high risk). The classification determines the regulatory requirements for market authorization, such as conformity assessment procedures, labeling, and post-market surveillance.

The inclusion of devices in eudamed depends on whether they are placed on the EU market and fall under the scope of EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Devices classified as Class I (excluding custom-made and sterile instruments) may not always require listing in eudamed unless they are part of a notified body’s certification process. Other devices, particularly those classified as Class IIa or Class III, are typically listed to demonstrate compliance and traceability.