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Polsiera Manopola
EUDAMEDClass I (EU MDR)
Ref 211NRSMModel ORTESI
by SAFTE S.r.l.
Identity
- Trade Name
- POLSIERA MANOPOLA EUDAMED
- Model / Reference
- ORTESI EUDAMED211NRSM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053904508495 EUDAMED
- Basic UDI-DI
- 805390450ORTESIK2 EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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 Manopola 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 1b0cb07f-15ae-4d2d-9e34-169ded806316 61 fields · synced Jul 30, 2026