Identity
- Trade Name
- Lucerna U-ARM EUDAMED
- Device Name
- Multifunctional Systems for Direct Digital Radiology EUDAMED
- Model / Reference
- Lucerna U-Arm EUDAMEDGMILOU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649996713032 EUDAMED
- Basic UDI-DI
- 7649996713Lucerna-UA-FaV9 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb 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
Lucerna U-ARM by General Medical Italia LTD Swiss Branch — Class IIb — 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 | 7649996713Lucerna-UA-FaV9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- General Medical Italia LTD Swiss Branch
- EUDAMED SRN
- CH-MF-000030023
- Authorised Representative
- ITALIAN RADIOLOGY INDUSTRY SRL IT-AR-000037736
Sources (1)
- EUDAMED b512d84d-ff55-4b2c-b07b-9f5f1c999e97 61 fields · synced Oct 6, 2026