EUDAMED device
Gumlines
EUDAMED device 00816063023760 · Align Technology Ltd.
Key facts
| Primary DI | 00816063023760 |
|---|---|
| Trade name | Gumlines |
| Device name | Gumlines |
| Reference or catalog number | 226797 |
| Model | Gumlines |
| Manufacturer | Align Technology Ltd. |
| Manufacturer SRN | IL-MF-000000745 |
| Risk class | Class I |
| EMDN code | V92 |
| EMDN description | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 2, 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: