11 Health Technologies Limited

11 Health Technologies Limited specializes in reusable smart pouches, specifically the SmartBag (SmartPouch). This product is designed to help manage and track medical supplies, medications, or patient items in healthcare environments. The company’s focus is on creating solutions that improve efficiency and accountability in clinical settings.

11 Health Technologies Limited is headquartered in the United States. The company’s location in the US aligns with its regulatory framework, as its devices are subject to FDA oversight.

The SmartBag (SmartPouch) from 11 Health Technologies Limited falls under the FDA’s Class I device classification. This classification is typically assigned to low-risk devices, though compliance with regulatory requirements—such as the 510(k) pathway—remains essential to demonstrate safety and performance.

The SmartBag (SmartPouch) is listed in the FDA’s 510(k) registry. This pathway is used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards before entering the market.