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Neuro-Eye Diagnostic Systems, LLC

United Statesfrom the FDA registration address FDA establishment FEI 3042954736

Devices
1
Registrations
FDA
FDA recalls
0

What Neuro-Eye Diagnostic Systems, LLC makes

Neuro-Eye Diagnostic Systems, LLC manufactures the EyeCTester, a device designed for ophthalmic diagnostic testing, likely assessing visual function or retinal health.

The EyeCTester is classified as a Class I medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • EyeCTester Ref K203594

    Active Regimes: 510(k) Registry: 510(k) Class:I

Company details

FDA FEI number
3042954736
Address
2020 Quenby St, Houston, TX, 77005

Frequently asked questions

How many devices does Neuro-Eye Diagnostic Systems, LLC have in the registry?

The registry currently lists 1 device for Neuro-Eye Diagnostic Systems, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Neuro-Eye Diagnostic Systems, LLC's devices?

Among its 1 most recently registered device, Neuro-Eye Diagnostic Systems, LLC has devices listed in FDA 510(k) (1 device).

What risk classes do Neuro-Eye Diagnostic Systems, LLC's devices fall under?

Among its 1 most recently registered device, the classes recorded for Neuro-Eye Diagnostic Systems, LLC's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Neuro-Eye Diagnostic Systems, LLC in the registry?

The most recently registered devices listed for Neuro-Eye Diagnostic Systems, LLC include EyeCTester.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.