EUDAMED device
iTero Element Scanner Sleeve
EUDAMED device 00816063020585 · Align Technology Ltd.
Key facts
| Primary DI | 00816063020585 |
|---|---|
| Trade name | iTero Element Scanner Sleeve |
| Device name | iTero Element Scanner Sleeves |
| Reference or catalog number | 109236 |
| Model | iTero Element Scanner Sleeves |
| Manufacturer | Align Technology Ltd. |
| Manufacturer SRN | IL-MF-000000745 |
| Risk class | Class IIa |
| EMDN code | Z12119085 |
| EMDN description | VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Feb 6, 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: