Identity
- Trade Name
- ELBA FISSA EUDAMED
- Device Name
- ELBA FISSA EUDAMED
- Model / Reference
- R13ELB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054726762379 EUDAMED
- Basic UDI-DI
- 805472676237FE EUDAMED
- EMDN Code
- V080699 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
Elba Fissa by Sogno Veneto S.p.A. — 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 | 805472676237FE | Class I | Active |
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Manufacturer
- Manufacturer
- Sogno Veneto S.p.A.
- EUDAMED SRN
- IT-MF-000048125
Sources (1)
- EUDAMED 35de820d-ca83-4f77-a714-eb63703b3bfa 61 fields · synced Jul 30, 2026