INTERMARK MEDICAL INNOVATIONS LIMITED

InterMark Medical Innovations Limited specializes in single-use medical devices for rectal applications. Their portfolio includes rectal medication applicators and rectal medication/infusion catheters, such as the Proctowash device. These products are designed to administer rectal medications or infusions in clinical environments.

InterMark Medical Innovations Limited is based in the United States. Their devices are developed and manufactured with a focus on compliance with U.S. regulatory standards.

InterMark Medical Innovations Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. regulatory requirements for medical devices.

InterMark Medical Innovations Limited’s devices fall under Class I classification in the U.S. regulatory framework. Class I devices are generally considered low-risk and are subject to the FDA’s 510(k) pathway for premarket notification, ensuring they meet safety and performance standards before entering the market.