Contura International A/S

Contura International A/S specializes in single-use, non-medicated urological surgical procedure kits. These kits are designed for specific urological interventions, ensuring minimal medication interaction and reducing the risk of contamination. The company’s focus is on sterile, disposable solutions tailored for surgical procedures in urology.

Contura International A/S is based in the United States. Since the company’s devices fall under FDA jurisdiction, they are subject to U.S. regulatory requirements, including classification under the FDA’s device hierarchy. The U.S. location also means its products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and identify medical devices for regulatory and market surveillance purposes.

Contura International A/S’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to maintain a standardized system for identifying medical devices, ensuring traceability and compliance with U.S. regulatory requirements. Listing in the UDI database helps healthcare providers, regulators, and other stakeholders verify device details and authenticity.

Contura International A/S’s devices are classified as Class III under FDA regulations. This classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require premarket approval (PMA) or a product development protocol (PDP) before they can be marketed, reflecting stricter scrutiny due to their critical role in patient care.