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Villa Sistemi Medicali DRF 4343-LT System DT

by Villa Sistemi Medicali SpA

Ref 8784000003Model DRF 4343-LT System

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08057737122040 UDI-DI Date4 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805773712FT258A5 Basic UDI-DI 08057737122040UDI-DIDate22 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
DRF 4343-LT System DT EUDAMED
Villa Sistemi Medicali GUDID
Generic Name
Diagnostic x-ray digital imaging system workstation
Device Name
DRF 4343-LT System
Model / Ref / Catalog
DRF 4343-LT System, 8784000003, DRF 4343-LT System DT
Primary DI / UDI-DI
08057737122040
Basic UDI-DI
805773712FT258A5
510(k) Number
FDA Product Code
MQB
EMDN Code
Z11039021 Radiography video acquisition systems
GMDN Term
Diagnostic x-ray digital imaging system workstation
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1680
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.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DRF 4343-LT System
8784000003
GUDID
DRF 4343-LT System DT
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K080859)

Other devices from Villa Sistemi Medicali SpA

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No