MEDIZS Inc.

MEDIZS Inc. specializes in devices used primarily for ophthalmic assessments. Their portfolio includes automated ophthalmic refractometers, which measure refractive error and corneal curvature, as well as phoropters for subjective refraction testing. They also produce vision testing and training charts—both traditional and digital—and visual acuity projectors. These tools are designed for clinical and educational use in eye care settings.

MEDIZS Inc. is based in the United States. As a manufacturer, it adheres to applicable US regulatory requirements for its devices, which are classified under the FDA’s regulatory system. Since all listed devices fall under Class I classification, they are subject to the least stringent regulatory controls among FDA categories, focusing on general controls and labeling requirements.

Yes, MEDIZS Inc.’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, including those like refractometers, phoropters, and visual acuity projectors, by assigning a standardized identifier to each product.

All MEDIZS Inc. devices listed fall under Class I classification in the US. This classification applies to low-risk devices like automated refractometers, phoropters, and vision charts, where the FDA’s regulatory oversight is minimal—primarily focusing on good manufacturing practices, labeling accuracy, and compliance with general device controls.