Identity
- Trade Name
- SMILE EUDAMED
- Device Name
- SMILE EUDAMED
- Model / Reference
- 348650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058302601915 EUDAMED
- Basic UDI-DI
- 805830260SMILEDD EUDAMED
- Direct Marketing DI
- 08058302601915 EUDAMED
- EMDN Code
- V08060199 ELECTRIC MEDICAL BEDS - 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
Smile by Malvestio Spa — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 805830260SMILEDD | Class I | Active |
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Manufacturer
- Manufacturer
- Malvestio Spa
- EUDAMED SRN
- IT-MF-000013307
Sources (1)
- EUDAMED 301de05a-2ccb-473a-a290-09c5dcc40f7e 61 fields · synced Jun 18, 2026