SMART VIDEO-STYLET, LLC

Smart Video-Stylet, LLC specializes in video-based laryngoscopes used for intubation procedures. Their portfolio includes a flexible, single-use video laryngoscope and a rigid, non-bladed video laryngoscope, both designed to provide real-time visualization of the airway during insertion. One of their devices, the Smart Video-Stylet Monitor, also includes a monitoring function for additional clinical feedback.

The company is headquartered in the United States, where it develops and manufactures its devices. Since their products fall under U.S. regulatory oversight, they adhere to applicable FDA requirements for medical devices, including those related to safety, performance, and labeling for procedural tools like laryngoscopes.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I medical devices, which includes their video laryngoscopes, by assigning a standardized identifier for tracking and compliance purposes.

All devices produced by Smart Video-Stylet, LLC fall under Class I classification according to FDA categorization. This classification applies to low-risk devices like laryngoscopes, which are generally considered safe and effective for their intended use without requiring stringent pre-market approval processes beyond basic registration and compliance.