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Tutore Bivalva Per Stabilizzazione Caviglia
EUDAMEDClass I (EU MDR)
Ref 470Model ORTESI
by SAFTE S.r.l.
Identity
- Trade Name
- TUTORE BIVALVA PER STABILIZZAZIONE CAVIGLIA EUDAMED
- Model / Reference
- ORTESI EUDAMED470 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056045436238 EUDAMED
- Basic UDI-DI
- 805390450ORTESIK2 EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-ANKLE-FOOT ORTHOSES 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
Tutore Bivalva Per Stabilizzazione Caviglia 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 | 805390450ORTESIK2 | Class I | Active |
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Manufacturer
- Manufacturer
- SAFTE S.r.l.
- EUDAMED SRN
- IT-MF-000011223
Sources (1)
- EUDAMED c9cefaa3-1ab7-44c9-b878-46149e6b28dc 61 fields · synced Jul 30, 2026