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Vision Assessment Corporation

United States US-MF-000047190 Last updated 21 Oct 2026

Devices
29
Registries
EUDAMED
FDA recalls
0

Catalogue29

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About

Pediatric Assessment of Stereopsis with a Smile This depth perception test is designed for school-age assessment of stereopsis in children and non-readers to check how well a child’s two eyes work together.

From the manufacturer's own website. Source

What Vision Assessment Corporation makes

Vision Assessment Corporation manufactures devices for clinical assessment of visual function, including automated tests for measuring stereopsis and depth perception in children and non-reading patients. These tools are used in pediatric eye care to evaluate binocular vision and identify issues with how the eyes coordinate. The portfolio includes both handheld and screen-based instruments for objective measurement of visual alignment and spatial awareness.

The company’s devices are classified as Class I under EU regulations and are registered in the EUDAMED database. While primarily focused on the European market, the manufacturer is based in the United States. No additional regulatory classifications or national registries outside the EU are specified.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Vision Assessment Corporation manufacture?

Vision Assessment Corporation specializes in devices for clinical assessment of visual function, particularly focusing on measuring stereopsis and depth perception. These tools are designed for pediatric and non-reading patients to evaluate how well their eyes work together, helping identify binocular vision issues. Examples include automated tests for depth perception and handheld instruments for objective measurement of visual alignment.

Where is Vision Assessment Corporation based, and where are its devices primarily registered?

Vision Assessment Corporation is headquartered in the United States. Its devices are registered in the EUDAMED database, which is the European Union’s regulatory database for medical devices. This registration reflects compliance with EU requirements, though the company’s primary market focus appears to be within Europe.

How are Vision Assessment Corporation’s devices classified under EU regulations?

Vision Assessment Corporation’s devices are classified as Class I under EU medical device regulations. This classification typically applies to low-risk devices, such as those used for diagnostic or monitoring purposes without invasive procedures. The classification ensures they meet basic safety and performance requirements before being registered in EUDAMED.

Are Vision Assessment Corporation’s devices listed in any other regulatory registries outside the EU?

Based on available information, Vision Assessment Corporation’s devices are only listed in the EUDAMED database. No other regulatory registries or classifications (e.g., FDA, national registries) are specified for these products. This suggests the company’s primary regulatory focus is currently within the European Union.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
5400, Newport Dr., Ste. 3, Rolling Meadows, United States
Phone
+001 847 239 5889
PRRC contact
Jacqueline Judy
EUDAMED SRN
US-MF-000047190