Medi-Tate , Ltd.

Medi-Tate, Ltd. specializes in bare-metal urethral stents intended for short-term use. These devices are primarily designed to address urethral strictures or obstructions temporarily. The company’s portfolio includes systems like the iTIND System, removal kits for these stents, and retrieval tools such as the SNARE, which assist in stent removal procedures.

Medi-Tate, Ltd. is based in the United States. The company’s devices, including the iTIND System and associated tools, fall under Class II classification in the US regulatory framework. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness.

Medi-Tate, Ltd.’s devices are listed in the FDA’s 510(k) Premarket Notification Database, which tracks devices deemed substantially equivalent to legally marketed predicates, and the FDA’s Unique Device Identifier (UDI) System, which standardizes device identification for tracking and regulatory purposes.

The company’s devices, such as the iTIND System, are designed for short-term urethral stenting to relieve obstructions or strictures. The associated removal kits (e.g., iTind Removal Kit) and retrieval tools (e.g., SNARE) ensure controlled deployment and safe retrieval when the stent is no longer needed, minimizing complications like tissue damage or stent migration.