Identity
- Trade Name
- SteadyTemp EUDAMED
- Device Name
- SteadyTemp EUDAMED
- Model / Reference
- 09120095900045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120095900045 EUDAMED
- Basic UDI-DI
- B-09120095900045 EUDAMED
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SteadyTemp by SteadySense GmbH — Class I — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233280 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-09120095900045 | Class I | Active |
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Manufacturer
- Manufacturer
- SteadySense GmbH
- EUDAMED SRN
- AT-MF-000003984
Sources (2)
- EUDAMED a63a017b-a776-4072-885f-d81d4f6a01f5 85 fields · synced Jun 18, 2026
- FDA 510(k) K233280 1 fields · synced May 18, 2026