Identity
- Trade Name
- GLENSOFT EUDAMED
- Device Name
- GLENSOFT EUDAMED
- Model / Reference
- GLENSOFT EUDAMEDGL12X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760270340097 EUDAMED
- Basic UDI-DI
- 376027034340107948485 EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Glensoft by Orthosoft — 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 | 376027034340107948485 | Class I | Active |
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Manufacturer
- Manufacturer
- Orthosoft
- EUDAMED SRN
- FR-MF-000000216
Sources (1)
- EUDAMED 1e01209d-9a90-49f0-92ea-3dbfb587cec5 61 fields · synced Jul 20, 2026