TEAC MANUFACTURING SOLUTIONS CORPORATION

Teac Manufacturing Solutions Corporation specializes in medical video image recorders. These devices are engineered to capture and store digital video footage from medical procedures and examinations, serving clinical environments for diagnostic, educational, and review purposes. The focus is on ensuring real-time imaging documentation is reliable and accessible.

The company is headquartered in the United States. This location aligns with its compliance obligations under U.S. regulatory frameworks, including those governing medical device traceability and identification.

Teac Manufacturing Solutions Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device can be uniquely identified, tracked, and verified for compliance with U.S. regulatory requirements, particularly for Class I devices which require such traceability.

Teac Manufacturing Solutions Corporation’s devices fall under Class I classification. This classification is assigned based on risk assessment criteria, where Class I devices are deemed low-risk and typically require minimal regulatory oversight. The classification reflects the relative safety and controlled nature of these medical video image recorders.