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 IIb | 25 |
|---|---|
| Class IIa | 156 |
Most frequent device types declared: ARTEMIS, Allia, MBE2, Pristina Serena.
Among these devices, 181 are declared active, 137 with a measuring function.
Devices declared under this manufacturer
- Bone VCAR
- CT Perfusion 4D
- CardEP
- CardIQ Suite
- CardIQ Xpress 2.0
- FastStroke
- FlightPlan for EVAR
- FlightPlan for Embolization
- HeartVision 2
- IGS WF SP
- TAVI Analysis
- VesselIQ Xpress
Showing 12 of 181 declared devices.
Catalogue references include 5796561, 5853351, 5854356, 5970978, 5970997, 5976261.
European nomenclature codes declared: Z11030692, Z11030192, Z11050192, Z11020492, Z11030102, Z11020492,Z11030192,Z11030692,Z11050192.
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 |
Device-level evidence
| Devices with a numeric GTIN | 181 |
|---|---|
| Found in the U.S. device database | 15 |
| Share | 8.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GE MEDICAL SYSTEMS SCS |
What it holds in Canada
| Licences on record | 17 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| Class 3 devices | 11 |
| First licensed | 2003-01-06 |
Licence types: System (7), Device Family (5), Single Device (4), Device Group (1).
Licensed under: IGS FIXED SINGLE INTERVENTIONAL ANGIOGRAPHIC X, SENOGRAPHE ESSENTIAL, INNOVA IGS BIPLANE INTERVENTIONAL ANGIOGRAPHIC, ADVANTAGESIM MD, SOFTWARE FOR MAMMOGRAPHY, ADVANTAGE WORKSTATION (AW).
North American profile: Both markets. GE Medical Systems SCS is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
38746 | supplemented | 2031-04-15 |