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Ortesi di spalla
EUDAMEDClass I (EU MDR)
Ref SOFT, mis.XLModel S.O.F.T.
by G.l.o. Srl
Identity
- Device Name
- Ortesi di spalla EUDAMED
- Model / Reference
- S.O.F.T. EUDAMEDSOFT, mis.XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051566281428 EUDAMED
- Basic UDI-DI
- 805156628SOFTHA EUDAMED
- EMDN Code
- Y060621 SHOULDER 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
Ortesi di spalla by G.l.o. Srl — 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 | 805156628SOFTHA | Class I | Active |
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Manufacturer
- Manufacturer
- G.l.o. Srl
- EUDAMED SRN
- IT-MF-000018554
Sources (2)
- EUDAMED 3e6e81fb-c4fe-4f07-90a4-a629625bb294 61 fields · synced Aug 4, 2026
- EUDAMED 3e6e81fb-c4fe-4f07-90a4-a629625bb294-1 61 fields · synced Jun 10, 2026