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Rialzo Tallone 3/4 Per Dismetrie
EUDAMEDClass I (EU MDR)
Ref 78D-2Model PROTEZIONE DEL PIEDE
by SAFTE S.r.l.
Identity
- Trade Name
- RIALZO TALLONE 3/4 PER DISMETRIE EUDAMED
- Model / Reference
- PROTEZIONE DEL PIEDE EUDAMED78D-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053904503537 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
Rialzo Tallone 3/4 Per Dismetrie by SAFTE S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 bbe4f784-9c30-4d10-9712-c32bcc448d97 61 fields · synced Aug 2, 2026