UDI device identifier
AEYE Health AEYE-DS
UDI device identifier 00085003651039 · Aeye Health, Inc.
Key facts
| Primary DI | 00085003651039 |
|---|---|
| Brand name | AEYE Health |
| Version or model | AEYE-DS |
| Company | Aeye Health, Inc. |
| DUNS number | 118503339 |
| Product code | PIB |
| GMDN term | Ophthalmic image clinical assessment support software, professional-only |
| Premarket submission | K221183 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Dec 12, 2024 |
| Version date | Sep 4, 2026 |
| Description | AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic… |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1–9 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: