AEYE HEALTH INC.

FDA Device Registration & Listing · New York, NY, US · Registration 3025301728

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025301728
FEI Number
3025301728
Entity Name
AEYE HEALTH INC.
City/State/Country
New York, NY, US
Establishment Address
1501 Broadway (Suite #12014), New York, NY 10036, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AEYE Health Inc. (Owner Number: 10086693)
Owner / Operator Contact Address
1501 Broadway (Suite #12014), New York, NY 10036, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240058
PMA Number
N/A

All Registered Proprietary Names

AEYE-DS AEYE-DS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PIB Diabetic Retinopathy Detection Device Ophthalmic Class 2 886.1100 2022-12-04
PIB Diabetic Retinopathy Detection Device Ophthalmic Class 2 886.1100 2024-12-15

Official Correspondent

Zack Dvey-Aharon, PhD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AEYE Health Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025301728. Last updated year: 2026. Please use registration number 3025301728 when referencing this establishment in official correspondence.
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