AEGEA MEDICAL INC.

AEGEA Medical Inc. specializes in devices used for endometrial ablation, a procedure to remove the uterine lining. Their products include a water vapour endometrial-ablation applicator (part of the Mara Water Vapor Probe Kit) and a control unit (the Mara Console). These devices work together to deliver precise water vapour energy for tissue ablation, helping treat conditions like heavy menstrual bleeding.

AEGEA Medical Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these products as Class III, which means they require premarket approval (PMA) due to their higher risk profile and intended use in critical procedures like endometrial ablation.

Yes, AEGEA Medical Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each device, improving traceability, safety monitoring, and compliance tracking. Listing in the UDI database ensures transparency for healthcare providers, regulators, and patients by providing clear, searchable details about the device’s specifications and regulatory status.

The FDA classifies AEGEA Medical Inc.’s endometrial ablation devices as Class III. This classification is the highest risk tier under FDA regulations and applies to devices that sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury. As a result, these devices require premarket approval (PMA)—a rigorous review process—to ensure their safety and effectiveness before they can be marketed.