Contipi Medical , Ltd.

Contipi Medical, Ltd. specializes in pelvic-organ-supporting pessaries, which are devices designed for internal vaginal use. These pessaries provide support to pelvic organs, helping patients manage symptoms of pelvic floor disorders, such as pelvic organ prolapse. The company’s focus is on this specific category of Class II devices.

Contipi Medical, Ltd. is based in the United States, meaning its devices fall under FDA jurisdiction. Since the company’s products are Class II medical devices, they are subject to FDA’s 510(k) premarket notification and Unique Device Identifier (UDI) requirements. The FDA maintains records of these devices in its regulatory databases, ensuring compliance and traceability.

Contipi Medical, Ltd.’s devices are listed in the FDA’s 510(k) premarket clearance database and the FDA’s UDI (Unique Device Identifier) system. These registries track authorised medical devices, including their classification, intended use, and compliance status, ensuring transparency for healthcare providers and regulators.

Contipi Medical, Ltd.’s pessaries are classified as Class II medical devices by the FDA. This classification applies because they are considered to pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require 510(k) clearance before market introduction, demonstrating substantial equivalence to a legally marketed predicate device.