Identity
- Trade Name
- 350N-SF-C EUDAMED
- Device Name
- Specchio Reclinabile Serie Soft EUDAMED
- Model / Reference
- 350N-SF-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054383331352 EUDAMED
- Basic UDI-DI
- 805438333SPESF00032 EUDAMED
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hydrotherapy bath/tank
350n-Sf-C by Thermomat Saniline S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805438333SPESF00032 | Class I | Active |
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Manufacturer
- Manufacturer
- Thermomat Saniline S.r.l.
- EUDAMED SRN
- IT-MF-000051936
Sources (1)
- EUDAMED 63635397-4b94-4009-bbfb-eee6782685ed 61 fields · synced Jun 18, 2026