Identity
- Trade Name
- FODERA DORMOSAN THERAPY EUDAMED
- Device Name
- MATERASSI E FEDERE EUDAMED
- Model / Reference
- FDTSTV100190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056994984323 EUDAMED
- Basic UDI-DI
- 805699498FT007DOR8 EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - 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
Yes
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 Therapy 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 | 805699498FT007DOR8 | Class I | Active |
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Manufacturer
- Manufacturer
- DF MEDICA Oone srl
- EUDAMED SRN
- IT-MF-000028375
Sources (1)
- EUDAMED e67d7016-ac9e-4aa9-804c-fed7846dcadb 61 fields · synced Jun 17, 2026