AIT Austrian Institute of Technology GmbH
AT-MF-000002398 · Austria · Vienna
AIT Austrian Institute of Technology GmbH is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Among these devices, 11 are declared active.
Devices declared under this manufacturer
- ARCSolver
- KITGuideMe
- KITMed
- UNEEG EpiSight Analyzer
- UNEEG™ EpiSight Analyzer
Showing 12 of 14 declared devices.
Catalogue references include ARCSolver 3.0, ARCSolver 4.0 Android, ARCSolver 4.0 LINUX, KITMed 2.1, KITMed 2.2, UNEEG EpiSight Analyzer 2.0.
European nomenclature codes declared: V92, N010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AIT AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH (AT) · FDA 3017374042 |
| Devices in EUDAMED | 14 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. AIT Austrian Institute of Technology GmbH is registered in the United States but was not found in the Canadian register.