UDI device identifier
AUTION EYE™ AI-4510 Analyzer 108861
UDI device identifier 00015482188627 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482188627 |
|---|---|
| Brand name | AUTION EYE™ AI-4510 Analyzer |
| Version or model | 108861 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | LKM |
| GMDN term | Urine analyser IVD, laboratory |
| Premarket submission | K232416 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Dec 2, 2024 |
| Version date | Aug 24, 2026 |
| Description | The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithilial cells (SQEC), the… |
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: