AIDOT

AIDOT specializes in manufacturing colposcopes, such as the Cerviray. These devices are designed to examine the cervix and vaginal walls with magnified, high-resolution imaging, helping healthcare providers detect abnormalities like dysplasia or cancerous lesions during gynecological evaluations.

AIDOT is based in the United States. Its devices are regulated under U.S. medical device laws, specifically falling under the FDA’s classification system. This ensures compliance with safety and performance standards for diagnostic imaging equipment like colposcopes.

AIDOT’s devices, including colposcopes like the Cerviray, are classified as Class II by the FDA. This classification is assigned based on the device’s intended use and associated risk level—Class II devices generally require special controls beyond general controls to ensure their safety and effectiveness, reflecting their role in critical diagnostic procedures.

Yes, AIDOT’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks device information to support transparency, traceability, and compliance monitoring for manufacturers and healthcare providers in the U.S.