EUDAMED device
Invisalign Palatal Expander
EUDAMED device 00816063021391 · Align Technology Inc.
Key facts
| Primary DI | 00816063021391 |
|---|---|
| Trade name | Invisalign Palatal Expander |
| Device name | Invisalign Palatal Expander System |
| Reference or catalog number | 9031 |
| Model | Invisalign Palatal Expander System |
| Manufacturer | Align Technology Inc. |
| Manufacturer SRN | US-MF-000000744 |
| Risk class | Class IIa |
| EMDN code | Q010499 |
| EMDN description | ORTHODONTIC DEVICES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Nov 22, 2024 |
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: