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Polsiera Steccata
EUDAMEDClass I (EU MDR)
Ref 225NRSMSModel ORTESI
by SAFTE S.r.l.
Identity
- Trade Name
- POLSIERA STECCATA EUDAMED
- Model / Reference
- ORTESI EUDAMED225NRSMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053904503315 EUDAMED
- Basic UDI-DI
- 805390450ORTESIK2 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Polsiera Steccata 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 0a0755ae-b24e-460d-b10d-81d98d48c694 61 fields · synced Aug 4, 2026