EUDAMED device
iTero Element 5D scanning unit, RMA
EUDAMED device 00816063021735 · Align Technology Ltd.
Key facts
| Primary DI | 00816063021735 |
|---|---|
| Trade name | iTero Element 5D scanning unit, RMA |
| Device name | iTero Element 5D Family |
| Reference or catalog number | 206955 |
| Model | iTero Element 5D Family |
| Manufacturer | Align Technology Ltd. |
| Manufacturer SRN | IL-MF-000000745 |
| Risk class | Class IIa |
| EMDN code | Z110601 |
| EMDN description | LASER IMAGING SCANNER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Feb 3, 2025 |
At a glance
- No 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: