Identity
- Trade Name
- Lucerna RF-TILT EUDAMED
- Device Name
- Multifunctional Systems for Direct Digital Radiology EUDAMED
- Model / Reference
- Lucerna RF-TILT EUDAMEDGMILOA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649996713049 EUDAMED
- Basic UDI-DI
- 7649996713Lucerna-RF-FaVB 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
Category: Stationary basic diagnostic x-ray system, digital
Lucerna RF-TILT by General Medical Italia LTD Swiss Branch — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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-RF-FaVB | 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 36555d08-f7f0-42c7-a0eb-9ef6e911a860 61 fields · synced Jul 9, 2026