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Virtua

by Codonics Inc.

Ref VirtuaModel Virtua Medical Disc Publisher

Virtua is a DICOM image data disc-recording unit (EU MDR Class I; FDA Class I; FDA product code LMD, System, Digital Image Communications, Radiological) made by Codonics Inc., registered in EUDAMED on 15 Feb 2024 (Basic UDI-DI 081490502VRMDP01KK) and listed in FDA GUDID since 27 Sep 2023 (UDI-DI 00814905020328), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081490502VRMDP01KK Basic UDI-DI 00814905020328UDI-DIDate15 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00814905020328 UDI-DI Date27 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081490502VRMDP01KK registered 15 Feb 2024 Active
  • FDA GUDID UDI-DI 00814905020328 listed 27 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00814905020328
  2. Registered EUDAMED 081490502VRMDP01KK

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  • Withdrawn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
Virtua EUDAMED
Codonics Virtua® Medical Disc Publisher GUDID
Generic name
DICOM image data disc-recording unit
Model / reference
Virtua Medical Disc Publisher, Virtua
Primary DI / UDI-DI
00814905020328
Basic UDI-DI
081490502VRMDP01KK
Direct marketing DI
00814905020328
FDA product code
LMD
EMDN code
Z11069099 Various digital bioimaging management instruments - other
GMDN term
DICOM image data disc-recording unit
Device class
Class I
Regulation number
892.2020
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000008190
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS.

Other devices from Codonics Inc.

See all devices from Codonics Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)