EUDAMED device
iTero Element Plus Wheel Stand, kit
EUDAMED device 00816063020981 · Align Technology Ltd.
Key facts
| Primary DI | 00816063020981 |
|---|---|
| Trade name | iTero Element Plus Wheel Stand, kit |
| Device name | Itero Wheel Stand |
| Reference or catalog number | 211563 |
| Model | Itero Wheel Stand |
| Manufacturer | Align Technology Ltd. |
| Manufacturer SRN | IL-MF-000000745 |
| Risk class | Class I |
| EMDN code | Q010299 |
| EMDN description | PROSTHETIC DENTISTRY DEVICES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | May 26, 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: