Identity
- Trade Name
- DORMOSAN UNICO EUDAMED
- Device Name
- GUANCIALI EUDAMED
- Model / Reference
- UNICO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056994980714 EUDAMED
- Basic UDI-DI
- 805699498FT004DOQR EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS 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
Dormosan Unico by DF MEDICA Oone srl — 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 | 805699498FT004DOQR | Class I | Active |
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Manufacturer
- Manufacturer
- DF MEDICA Oone srl
- EUDAMED SRN
- IT-MF-000028375
Sources (1)
- EUDAMED 31c56c54-fa6d-433b-bf97-25f95ab04ee4 61 fields · synced Jul 8, 2026