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Soletta In Silicone
EUDAMEDClass I (EU MDR)
Ref 132LRModel PROTEZIONE DEL PIEDE
by SAFTE S.r.l.
Identity
- Trade Name
- SOLETTA IN SILICONE EUDAMED
- Model / Reference
- PROTEZIONE DEL PIEDE EUDAMED132LR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053904508433 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Soletta In Silicone by SAFTE S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 774fa7ed-8e22-42c4-95f0-37950da2d1a5 61 fields · synced Aug 2, 2026