Identity
- Device Name
- Ortesi spalla EUDAMED
- Model / Reference
- 422 EUDAMED422, mis.L/XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055965373616 EUDAMED
- Basic UDI-DI
- 805596537422HS 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 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 | 805596537422HS | Class I | Active |
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Manufacturer
- Manufacturer
- G.l.o. Srl
- EUDAMED SRN
- IT-MF-000018554
Sources (2)
- EUDAMED 105d54c8-63e7-4f06-8877-8b0235e6735c 61 fields · synced Jun 18, 2026
- EUDAMED 105d54c8-63e7-4f06-8877-8b0235e6735c-1 61 fields · synced Jun 10, 2026