EUDAMED device
iTero Lumina Pro Software
EUDAMED device 00816063023067 · Align Technology Ltd.
Key facts
| Primary DI | 00816063023067 |
|---|---|
| Trade name | iTero Lumina Pro Software |
| Device name | iTero Lumina Pro Software |
| Reference or catalog number | 225979 |
| Model | iTero Lumina Pro Software |
| Manufacturer | Align Technology Ltd. |
| Manufacturer SRN | IL-MF-000000745 |
| Risk class | Class IIa |
| EMDN code | V92 |
| EMDN description | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Apr 24, 2025 |
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: