Identity
- Trade Name
- FODERA DORMOSAN H&H EUDAMED
- Device Name
- MATERASSI E FEDERE EUDAMED
- Model / Reference
- FHEHS02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056994981322 EUDAMED
- Basic UDI-DI
- 805699498FT008DORD EUDAMED
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES 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
Fodera Dormosan H&H 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 | 805699498FT008DORD | Class I | Active |
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Manufacturer
- Manufacturer
- DF MEDICA Oone srl
- EUDAMED SRN
- IT-MF-000028375
Sources (1)
- EUDAMED 2f696b26-e8b2-4642-b9ac-b7c0f4d206e2 61 fields · synced Jun 19, 2026