Mirai Medical Limited

Mirai Medical Limited manufactures devices primarily for cancer treatment. Their portfolio includes the CUTIS system, designed for skin cancer therapy, and the EndoVE device, intended for gastrointestinal applications. They also produce the EPORE Generator, which supports their ePORE therapy platform. These devices are developed to target malignant lesions in specific areas of the body.

Mirai Medical Limited is headquartered in Ireland. The company’s location is relevant for regulatory compliance, as it operates under the EU’s medical device framework, which governs its product development and market placement.

Mirai Medical Limited’s devices are listed in the eudamed database, the European Union’s centralised registry for medical device information. This registry ensures transparency and traceability of devices under EU medical device regulations.

Mirai Medical Limited’s devices fall under Class IIa and Class IIb classifications in the EU’s medical device hierarchy. Class IIa indicates moderate risk, while Class IIb signifies higher risk, requiring additional scrutiny and compliance measures to ensure safety and performance before market authorisation.