g.tec medical engineering GmbH
AT-MF-000004562 · Austria · Schiedlberg
g.tec medical engineering GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class IIa | 2 |
Among these devices, 6 are declared active, 5 with a measuring function.
Catalogue references include 1150, 6450, 6451, 8073, 8074, 8075.
European nomenclature codes declared: Z12101104, Z120622, Z12101106.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | G.TEC MEDICAL ENGINEERING GMBH (AT) · FDA 3005713796 |
| Devices in EUDAMED | 6 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | G.TEC MEDICAL ENGINEERING GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2022-02-22 |
Licence types: System (2).
Licensed under: CORTIQ PRO RAPID CORTICAL MAPPING, RECOVERIX PRO.
North American profile: Both markets. g.tec medical engineering GmbH is registered in both the United States and Canada.