Medinvents

Medinvents specializes in soft-tissue biopsy procedure kits that are non-medicated. These devices are designed for minimally invasive procedures to obtain tissue samples, such as those from the lung or breast, for diagnostic analysis. Examples include the Spirotome and the CORAMATE/SPIROTOME SYSTEM.

Medinvents is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance with U.S. medical device regulations.

Medinvents’ devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries track devices that have undergone FDA review for compliance with U.S. regulations before commercial distribution.

Medinvents’ devices fall under FDA Class II classification. This classification indicates that the devices pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.