GE Medical Systems SCS
FR-MF-000000687 · France · BUC
GE Medical Systems SCS is registered in the European database on medical devices as a manufacturer, with 181 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 156 |
|---|---|
| Class IIb | 25 |
Most frequent device types declared: Allia, MBE2, ARTEMIS, Pristina Serena.
Among these devices, 181 are declared active, 137 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GE MEDICAL SYSTEMS SCS (FR) · FDA 9611343 |
| Devices in EUDAMED | 181 |
| Country of registration | France |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
38746 | supplemented | 2031-04-15 |