EUDAMED device
NGENUITY
EUDAMED device 00380650003997 · Alcon Laboratories, Inc.
Key facts
| Primary DI | 00380650003997 |
|---|---|
| Trade name | NGENUITY |
| Device name | NGENUITY 1.5 |
| Reference or catalog number | 8065000399 |
| Manufacturer | Alcon Laboratories, Inc. |
| Manufacturer SRN | US-MF-000016248 |
| Risk class | Class IIa |
| EMDN code | Z12120199 |
| EMDN description | OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jan 8, 2026 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: