EUDAMED device
Impressa/Chrome
EUDAMED device 00190746008122 · American Orthodontics
Key facts
| Primary DI | 00190746008122 |
|---|---|
| Trade name | Impressa/Chrome |
| Device name | Impressa/Chrome |
| Reference or catalog number | 861-131 |
| Manufacturer | American Orthodontics |
| Manufacturer SRN | US-MF-000007702 |
| Risk class | Class I |
| EMDN code | Q010499 |
| EMDN description | ORTHODONTIC DEVICES - OTHER |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Aug 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: