General ASDE, S.A.

General ASDE, S.A. specializes in visual acuity testing devices. Their portfolio includes optotypes for near-vision and distance testing (such as illuminated optotypes), tangent screen displays, and tools like the ASDE Driver Test N-845, which assesses visual and cognitive abilities relevant to driving. These devices are designed to evaluate vision-related functions in clinical or testing environments.

General ASDE, S.A. is based in Spain. Their devices are developed in compliance with EU medical device regulations, ensuring they meet the necessary safety, performance, and quality standards for the European market. Since their products fall under EU Class I classification, they must adhere to the applicable EU directives and requirements for such devices.

Yes, General ASDE, S.A.’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. This registry is used to track and monitor devices that have been authorized for placement on the EU market, ensuring transparency and traceability for regulatory oversight.

All of General ASDE, S.A.’s devices fall under EU Class I classification. This classification is assigned based on the risk associated with the device’s intended purpose and design. Class I devices are generally considered low-risk, but they still must comply with EU regulatory requirements to ensure safety and proper functionality before being authorized for market placement.