GE Healthcare Austria GmbH & Co OG
AT-MF-000001461 · Austria · ZIPF
GE Healthcare Austria GmbH & Co OG is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 26 |
|---|
Most frequent device types declared: C2-9-RS, IC9-RS, RAB2-6-RS, RAB6-D, RAB6-RS.
Among these devices, 25 are declared active, 14 with a measuring function.
Devices declared under this manufacturer
- C2-9-RS
- IC9-RS
- RAB2-6-RS
- RAB6-D
- RAB6-RS
- RIC10-D
- RIC5-9-D
- RM7C
- Voluson Expert 18 BT27
- Voluson Expert 22
- Voluson Expert 22 BT25
- VolusonExp BT24 to BT25 UPG
Showing 12 of 26 declared devices.
Catalogue references include 5761811, 5805692, H48691LP, Voluson Exp to BT24 UPG, Voluson Expert 20 BT24, Voluson Expert 22 BT24.
European nomenclature codes declared: Z11040104, Z1104020202, Z110402010202, Z110402010402, Z110402010201, Z11040192.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GE Healthcare Austria GmbH & Co OG (AT) · FDA 8020021 |
| Devices in EUDAMED | 26 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 26 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 80.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GE HEALTHCARE AUSTRIA GMBH & CO OG |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 3 |
| First licensed | 2010-01-04 |
Licence types: Device Family (3), Single Device (1).
Licensed under: PROBES FOR ULTRASOUND (KRETZTECHNIK), 4D VIEW, VOLUSON E-SERIES ULTRASOUND SYSTEM, VOLUSON EXPERT.
North American profile: Both markets. GE Healthcare Austria GmbH & Co OG is registered in both the United States and Canada.