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DRF 4343-LT System DT
EUDAMEDClass IIb (EU MDR)
Ref 8793000001Model DRF 4343-LT System
Identity
- Trade Name
- DRF 4343-LT System DT EUDAMED
- Device Name
- DRF 4343-LT System EUDAMED
- Model / Reference
- DRF 4343-LT System EUDAMED8793000001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057737122057 EUDAMED
- Basic UDI-DI
- 805773712FT258A5 EUDAMED
- EMDN Code
- Z11039021 RADIOGRAPHY VIDEO ACQUISITION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- DRF 4343-LT SYSTEM is an X-ray digital image acquisition and processing system adopting a dynamic X-ray flat panel detector, which allows to perform static and dynamic radiological diagnostic exams in real time. DRF 4343-LT SYSTEM can provide images and dynamic digital sequences of adult and pediatric subjects within diagnostic radiology applications, without limitations on the target patient population. DRF 4343-LT SYSTEM is intended for use by healthcare professionals such as radiographers/radiology technicians working in general radiology diagnostic rooms or emergency rooms. The use of DRF 4343-LT SYSTEM for mammography and dental radiology is excluded. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
DRF 4343-LT System DT by Villa Sistemi Medicali S.p.a. — 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 | 805773712FT258A5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Villa Sistemi Medicali S.p.A.
- EUDAMED SRN
- IT-PR-000027254
Sources (1)
- EUDAMED e6ccfa8b-4acd-44b3-b143-7d85bf7294f1 61 fields · synced Jun 18, 2026