NERBIO PRIVATE LIMITED

Nerbio Private Limited specializes in block-monitoring peripheral nerve electrical stimulation systems, which are designed to deliver targeted electrical stimulation to peripheral nerves for therapeutic or diagnostic applications. Their primary example device, the iTOF, focuses on precise stimulation and real-time monitoring of nerve function.

Nerbio Private Limited is based in the United States, where it develops and manufactures its devices in compliance with U.S. regulatory requirements. The company’s location influences which regulatory bodies oversee its products, such as the FDA, which classifies its devices under applicable U.S. regulations.

Nerbio Private Limited’s devices fall under FDA Class II classification, which typically indicates moderate risk and requires compliance with specific controls, such as performance standards or post-market surveillance. This classification helps determine the regulatory pathway and oversight required for their products.

Yes, Nerbio Private Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database, which serves as a public registry for tracking medical devices authorized in the U.S. This listing helps ensure transparency and traceability of their products within the regulatory system.