Data / Medical devices / Austria / Steadysense GMBH
Steadysense GMBH: FDA-registered device maker in Raaba-Grambach Steiermark, Austria, 1 510(k) clearance
Steadysense GMBH is registered with the FDA (registration 3016866092) in Raaba-Grambach Steiermark, Austria. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016866092
- Address
- Johann-Schreiner-Strase 3, Raaba-Grambach Steiermark, Austria, 8074
- Owner or operator
- SteadySense GmbH (10073696)
- Roles
- Manufacturer
- First device listed
- May 13, 2020
- Registered through
- 2026
- Brand names listed
- SteadyTemp, femSense Fertility, femSense Kinderwunsch, femSense Ovulation Tracker
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Device, Fertility Diagnostic, Proceptive | LHD | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 21, 2024 | K233280 | SteadyTemp | FLL | Substantially Equivalent | Steadysense GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Device, Fertility Diagnostic, Proceptive
Updated June 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.