SteadySense GmbH
AT-MF-000003984 · Austria · Raaba-Grambach
SteadySense GmbH is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Among these devices, 15 are declared active, 7 with a measuring function.
Devices declared under this manufacturer
- SteadySense Patch
- SteadySense Patch Sensitive
- SteadyTemp
- femSense
- femSense Fertility
- medicare femSense
Showing 12 of 15 declared devices.
Catalogue references include 09120095900069, 09120095900090, 09120095900250, 09120095900342, 09120095900373, 09120095900434.
European nomenclature codes declared: V030199, W0102160399, V0399, V03010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STEADYSENSE GMBH (AT) · FDA 3016866092 |
| Devices in EUDAMED | 15 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 6.7 % |
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. SteadySense GmbH is registered in the United States but was not found in the Canadian register.