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VirtuEye

by Fiagon GmbH

Ref E 01 1430Model Accessory to Cube4D Navigation system / registration device, non-tactile

VirtuEye (E 01 1430) is an ENT stereotactic surgery system (EU MDR Class I; FDA Class II; FDA product code PGW, Ear, Nose, And Throat Stereotaxic Instrument) made by Fiagon GmbH, registered in EUDAMED on 10 Jul 2024 (Basic UDI-DI 426075993E0046F), cleared under FDA 510(k) K211291 on 19 Jul 2021 and listed in FDA GUDID since 2 Sep 2024 (UDI-DI 04260759930126), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), partly in commercial distribution.

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211291

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260759930126 UDI-DI Date2 Sep 2024ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution
European UnionCE/MDR EUDAMED Number426075993E0046F Basic UDI-DI 04260759930126UDI-DIDate10 Jul 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211291 Date19 Jul 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426075993E0046F registered 10 Jul 2024 Active
  • FDA 510(k) K211291 decided 19 Jul 2021 Active
  • FDA GUDID UDI-DI 04260759930126 listed 2 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211291
  2. Registered EUDAMED 426075993E0046F
  3. Listed FDA GUDID 04260759930126

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
ENT stereotactic surgery system
Model / Ref / Catalog
Accessory to Cube4D Navigation system / registration device, non-tactile, E 01 1430, E011430, v2
Description
Accessory to Cube navigation systems. Device for registration.
Primary DI / UDI-DI
04260759930126, EFIAE0114301
Basic UDI-DI
426075993E0046F
Direct marketing DI
04260759930126
510(k) Number
FDA product code
PGW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
ENT stereotactic surgery system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution (UDI-DI 04260759930126)
Not in Commercial Distribution (UDI-DI EFIAE0114301)

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Accessory to Cube4D Navigation system / registration device, non-tactile
E 01 1430
GUDID
E011430
v2
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DE-MF-000010763

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Fiagon GmbH

See all devices from Fiagon GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)