LORTE TECHNOLOGIES, INC

Lorte Technologies, Inc. specializes in three primary device categories: pulse oximeters (which measure oxygen saturation and heart rate non-invasively), foetal Doppler systems (used to monitor unborn foetal heartbeats), and single-use temperature probes for general patient temperature monitoring. These devices are designed for non-invasive, real-time monitoring in clinical and home settings.

Lorte Technologies, Inc. is headquartered in the United States. The company’s location ensures compliance with US regulatory standards, which govern the design, manufacturing, and distribution of its medical devices.

Lorte Technologies, Inc.’s devices are classified as Class II under the US Food and Drug Administration (FDA) regulatory framework. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, or labeling requirements.

Yes, Lorte Technologies, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, allowing regulators, healthcare providers, and patients to identify and track specific devices throughout their lifecycle.

Listing in the FDA UDI database means that each of Lorte Technologies, Inc.’s devices has been assigned a unique identifier, combining a device identifier (e.g., model number) and a production identifier (e.g., lot/batch number). This system helps streamline recall processes, improve patient safety by enabling better device tracking, and supports compliance with regulatory requirements for transparency in the medical device industry.