SERENE MEDICAL, INC.

Serene Medical, Inc. specializes in two primary device categories: single-use endoscopic electrosurgical handpieces and bipolar electrodes, which are used in minimally invasive surgical procedures, and radio-frequency ablation system generators designed for percutaneous tissue ablation. These devices are engineered to deliver controlled energy for precise surgical outcomes.

Serene Medical, Inc. is based in the United States, meaning its devices must comply with FDA regulations. The company’s products are classified as Class II, which requires adherence to specific controls, including performance standards and post-market surveillance, to ensure safety and effectiveness before authorisation.

Serene Medical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification, for compliance and safety purposes.

Serene Medical, Inc.’s devices are classified as Class II under regulatory frameworks. This classification indicates moderate risk, requiring additional controls beyond general good manufacturing practices, such as special controls or performance standards, to ensure their safety and effectiveness before authorisation.