GE Vingmed Ultrasound AS
NO-MF-000000553 · Norway · HORTEN
GE Vingmed Ultrasound AS is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 46 |
|---|
Most frequent device types declared: 6Tc, 9T, P2D, P6D, Vivid E95_Vivid E90_Vivid E80.
Among these devices, 46 are declared active, 31 with a measuring function.
Devices declared under this manufacturer
- 6Tc-RS
- 9T
- P2D
- P2D-RS
- P2D-RSE
- P6D-RS
- Vivid E90
- Vivid E95
- Vivid Focus
- Vivid Pioneer
- Vivid S60N
- Vivid S70N
Showing 12 of 46 declared devices.
Catalogue references include GN000100, KE100002, KQ100007, TC001005, TE100024, Vivid E95 v206.
European nomenclature codes declared: Z11040102, Z11040192, Z1104020302, Z11040299, Z110402010101,Z110402010201, Z110402010101,Z110402010301.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GE Vingmed Ultrasound AS (NO) · FDA 3033508292 |
| Devices in EUDAMED | 46 |
| Country of registration | Norway |
Device-level evidence
| Devices with a numeric GTIN | 46 |
|---|---|
| Found in the U.S. device database | 36 |
| Share | 78.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GE VINGMED ULTRASOUND AS |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 10 |
| First licensed | 2005-12-16 |
Licence types: Device Family (5), System (3), Single Device (3).
Licensed under: ECHOPAC DIMENSION CLINICAL WORKSTATION, VIVID E9 ULTRASOUND SYSTEM, PROBES FOR ULTRASOUND, VSCAN ULTRASOUND SYSTEM, VSCAN WITH DUAL PROBE, VIVID E-SERIES ULTRASOUND SYSTEMS.
North American profile: Both markets. GE Vingmed Ultrasound AS is registered in both the United States and Canada.