EUDAMED device
AMX Navigate
EUDAMED device 00195278003348 · GE Medical Systems, LLC
Key facts
| Primary DI | 00195278003348 |
|---|---|
| Trade name | AMX Navigate |
| Device name | AMX Navigate |
| Reference or catalog number | S4000DB, S4000DF |
| Manufacturer | GE Medical Systems, LLC |
| Manufacturer SRN | US-MF-000018315 |
| Risk class | Class IIb |
| EMDN code | Z11039016 |
| EMDN description | MOBILE RADIOGRAPHIC UNITS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | May 3, 2023 |
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)