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LEO-Surgical Lights (including Portegra)
EUDAMEDClass I (EU MDR)
Ref LE90046-SIModel LEO
by MAVIG GmbH
Identity
- Trade Name
- LEO-Surgical Lights (including Portegra) EUDAMED
- Device Name
- LEO Surgical Lights (including Portegra) EUDAMED
- Model / Reference
- LEO EUDAMEDLE90046-SI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251339901742 EUDAMED
- Basic UDI-DI
- 4251339900455VY EUDAMED
- EMDN Code
- Z12010701,Z12010702 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The surgical lights are designed to illuminate a surgical site (e.g. in a laboratory, hospital or doctor's practice) with focused, low-glare and shadow-free light. They enable the user to diagnose or perform medical procedures. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
LEO-Surgical Lights (including Portegra) by MAVIG GmbH — 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 | 4251339900455VY | Class I | Active |
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Manufacturer
- Manufacturer
- MAVIG GmbH
- EUDAMED SRN
- DE-PR-000020388
Sources (1)
- EUDAMED e4234242-7390-4eb7-b191-86d7082af6ba 61 fields · synced Jun 19, 2026