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Eidon Fa

by Centervue S.P.A.

Ref AIFLAME001

Eidon Fa (AIFLAME001) is a scanning-laser retinal imaging system (EU MDR Class IIa; FDA Class II) made by Centervue S.P.A., registered in EUDAMED on 2 Oct 2024 (Basic UDI-DI 805367704Eidon-FamilyUV), cleared under FDA 510(k) K180526 on 16 Jul 2018 and listed in FDA GUDID since 23 Jul 2018 (UDI-DI 08053677040093), active as of 24 Oct 2026.

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

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) K180526↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805367704Eidon-FamilyUV Basic UDI-DI 08053677040093UDI-DIDate2 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08053677040093 UDI-DI Date23 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK180526 Date16 Jul 2018IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805367704Eidon-FamilyUV registered 2 Oct 2024 Active
  • FDA 510(k) K180526 decided 16 Jul 2018 Active
  • FDA GUDID UDI-DI 08053677040093 listed 23 Jul 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180526
  2. Listed FDA GUDID 08053677040093
  3. Registered EUDAMED 805367704Eidon-FamilyUV

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Eidon Fa EUDAMED
Eidon GUDID
Generic name
Scanning-laser retinal imaging system
Device name
EIDON Family
Model / Ref / Catalog
AIFLAME001 EUDAMED
EIDON FA GUDID
APFLAOP100 GUDID
Primary DI / UDI-DI
08053677040093
Basic UDI-DI
805367704Eidon-FamilyUV, B-08053677040093
Direct marketing DI
08053677040093
FDA product code
MYC, HKI
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, 886.1120
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AIFLAME001
GUDID
EIDON FA
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)