Identity
- Trade Name
- ELBA DELUXE FISSA EUDAMED
- Device Name
- ELBA DELUXE FISSA EUDAMED
- Model / Reference
- R13EDEF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054726762461 EUDAMED
- Basic UDI-DI
- 805472676246FF 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 Deluxe 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 | 805472676246FF | Class I | Active |
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Manufacturer
- Manufacturer
- Sogno Veneto S.p.A.
- EUDAMED SRN
- IT-MF-000048125
Sources (1)
- EUDAMED f0f5d78e-c48e-463f-a9bb-5e71f832b8f9 61 fields · synced Aug 5, 2026