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Eidon

by Centervue S.P.A.

Ref AMFUNME001

Eidon (AMFUNME001) is a scanning-laser retinal imaging system (EU MDD Class IIa; FDA Class II; FDA product code MYC, Ophthalmoscope,Laser,Scanning) made by Centervue S.P.A., registered in EUDAMED on 26 Nov 2021 (Basic UDI-DI B-08053677040031), cleared under FDA 510(k) K142047 on 12 Nov 2014 and listed in FDA GUDID since 29 Jul 2016 (UDI-DI 08053677040031), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142047

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08053677040031 Basic UDI-DI 08053677040031UDI-DIDate26 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08053677040031 UDI-DI Date29 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK142047 Date12 Nov 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08053677040031 registered 26 Nov 2021 Active
  • FDA 510(k) K142047 decided 12 Nov 2014 Active
  • FDA GUDID UDI-DI 08053677040031 listed 29 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142047
  2. Listed FDA GUDID 08053677040031
  3. Registered EUDAMED B-08053677040031

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Scanning-laser retinal imaging system
Device name
EIDON Family
Model / Ref / Catalog
AMFUNME001 EUDAMED
EIDON GUDID
AMFUNME01 GUDID
Primary DI / UDI-DI
08053677040031
Basic UDI-DI
B-08053677040031, 805367704Eidon-FamilyUV
Direct marketing DI
08053677040031
FDA product code
MYC
EMDN code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
GMDN term
Scanning-laser retinal imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1570
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AMFUNME001
GUDID
EIDON
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
IT-MF-000017082

Similar devices in this category

Other devices filed under OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER.

Other devices from Centervue S.P.A.

See all devices from Centervue S.P.A. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (22, all answered No)