EU Manufacturer
🇦🇹 Austria
Active
SteadySense GmbH
SRN: AT-MF-000003984
·
Johann-Schreiner-Strasse 3, 8074 Raaba-Grambach, Austria
Basic UDI-DIs
2
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Johann-Schreiner-Strasse 3, 8074 Raaba-Grambach, Austria
- [email protected]
- Phone
- +43316232004
- Website
- www.steadysense.at
Regulatory Overview
Regulation
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Eu Mdd
1
Eu Mdr
1
Classification
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Eu Md Class 1
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 110321N5 | SLG PRÜF UND ZERTIFIZIERUNGS GMBH | Dec 31, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| SteadyTemp | EU MDD | Eu Md Class 1 | On Market | 1 |
| femSense | EU MDR | Eu Md Class 1 | On Market | 0 |
| femSense | EU MDR | Eu Md Class 1 | On Market | 0 |
| femSense Fertility | EU MDR | Eu Md Class 1 | On Market | 0 |
| medicare femSense | EU MDR | Eu Md Class 1 | On Market | 0 |