Tatch Inc.

Tatch Inc. makes polysomnographs and sleep disorder interpretive software intended for professional-only use, as stated in the device data. These products are designed to monitor and analyze sleep-related physiological data, with examples including CASSIE and Wesper Lab. The company focuses exclusively on these two device categories, which are listed as their most common offerings.

Tatch Inc. is based in the United States, as explicitly stated in the device data under the COUNTRY field. The summary also confirms the company's location in the United States, with no additional details about specific cities, states, or facilities provided in the source material.

Tatch Inc.'s devices are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field of the device data. This registry is used to track and identify medical devices sold in the United States, and the company's inclusion in it reflects regulatory tracking, not approval or clearance of the devices themselves.

Tatch Inc.'s devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field of the device data. This classification indicates that the devices require special controls to ensure safety and effectiveness, but it does not imply that the company or its devices are approved, certified, or cleared by any regulatory body—only individual devices may receive such authorizations.