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DRF 4343-LT System DT

EUDAMED

Class IIb (EU MDR)

Ref 8793000001Model DRF 4343-LT System

by Villa Sistemi Medicali S.p.A.

Identity

Trade Name
DRF 4343-LT System DT EUDAMED
Device Name
DRF 4343-LT System EUDAMED
Model / Reference
DRF 4343-LT System EUDAMED
8793000001 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

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Manufacturer

EUDAMED SRN
IT-PR-000027254

Sources (1)

  • EUDAMED e6ccfa8b-4acd-44b3-b143-7d85bf7294f1 61 fields · synced Jun 18, 2026