EUDAMED device
iFit Tube
EUDAMED device 00190746059124 · American Orthodontics
Key facts
| Primary DI | 00190746059124 |
|---|---|
| Trade name | iFit Tube |
| Device name | iFit Tube |
| Reference or catalog number | 1951-18-035575HM |
| Manufacturer | American Orthodontics |
| Manufacturer SRN | US-MF-000007702 |
| Risk class | Class IIa |
| EMDN code | Q010403 |
| EMDN description | ORTHODONTIC BRACKETS AND BUTTONS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Aug 1, 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: