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Soletta In Silicone Rivestito
EUDAMEDClass I (EU MDR)
Ref 107-1Model PROTEZIONE DEL PIEDE
by SAFTE S.r.l.
Identity
- Trade Name
- SOLETTA IN SILICONE RIVESTITO EUDAMED
- Model / Reference
- PROTEZIONE DEL PIEDE EUDAMED107-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056045438393 EUDAMED
- Basic UDI-DI
- 805390450PROTEZPIEDES3 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Soletta In Silicone Rivestito by SAFTE S.r.l. — 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 | 805390450PROTEZPIEDES3 | Class I | Active |
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Manufacturer
- Manufacturer
- SAFTE S.r.l.
- EUDAMED SRN
- IT-MF-000011223
Sources (1)
- EUDAMED 3974753f-bf11-4b57-ab2b-b6068de11a2a 61 fields · synced Jul 9, 2026