EUDAMED device
X-Guide
EUDAMED device 00817421020001 · X-Nav Technologies, LLC
Key facts
| Primary DI | 00817421020001 |
|---|---|
| Trade name | X-Guide |
| Device name | X-GUIDE PLANNING SOFTWARE |
| Reference or catalog number | P008296 |
| Model | P008296 |
| Manufacturer | X-Nav Technologies, LLC |
| Manufacturer SRN | US-MF-000003234 |
| Risk class | Class IIa |
| EMDN code | Z12011492 |
| EMDN description | SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Oct 28, 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: