EUDAMED device
Caption Guidance
EUDAMED device 00198953038604 · GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Key facts
| Primary DI | 00198953038604 |
|---|---|
| Trade name | Caption Guidance |
| Device name | Caption AI |
| Reference or catalog number | 5700635 |
| Model | 5700645 |
| Manufacturer | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC |
| Manufacturer SRN | US-MF-000016119 |
| Risk class | Class IIa |
| EMDN code | Z11040182 |
| EMDN description | ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 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: