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SteadyTemp
EUDAMEDClass I (EU MDR)
Ref 09120095900564Ref 09120095900342Ref 09120095900328Ref 09120095900335
Identity
- Trade Name
- SteadyTemp EUDAMED
- Device Name
- SteadyTemp EUDAMED
- Model / Reference
- 09120095900564 EUDAMED09120095900342 EUDAMED09120095900328 EUDAMED09120095900335 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120095900564 EUDAMED09120095900342 EUDAMED09120095900328 EUDAMED09120095900335 EUDAMED
- Basic UDI-DI
- B-09120095900564 EUDAMEDB-09120095900342 EUDAMED912009590TEMP01A7 EUDAMED
- Direct Marketing DI
- 09120095900328 EUDAMED09120095900335 EUDAMED
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SteadyTemp by SteadySense GmbH — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-09120095900564 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-09120095900564 | Class I | Active |
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Manufacturer
- Manufacturer
- SteadySense GmbH
- EUDAMED SRN
- AT-MF-000003984
Sources (4)
- EUDAMED b0453e10-b44e-4cfe-b405-6fc7d80fc37a 61 fields · synced Aug 4, 2026
- EUDAMED d1123a91-914d-41b7-a864-396fb0ff2e40 61 fields · synced May 18, 2026
- EUDAMED 68c790e8-90af-49aa-b451-247023f4a796 61 fields · synced Jul 31, 2026
- EUDAMED b4da4350-0e14-4958-a0aa-d8bd6233e8f7 61 fields · synced Aug 2, 2026