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Eidon Fa, Eidon, Eidon Af, Eidon Uwfl

by Centervue S.P.A.

510(k) K211328

Active European Union and United States

CE MDR 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) K211328↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK211328 Date19 Aug 2021ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211328 decided 19 Aug 2021 Active
  • EUDAMED Active· +1 more in the status table

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MYC
Device class
Class II
Regulation
21 CFR Part 886.1570
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Eidon FA, Eidon, Eidon AF, and Eidon UWFL are Scanning Laser Ophthalmoscopes, designed for retinal imaging and diagnostic evaluation of the eye. These devices utilize laser scanning technology to capture high-resolution images of the retina, enabling clinicians to assess retinal health, detect abnormalities, and monitor conditions such as diabetic retinopathy, glaucoma, and age-related macular degeneration (AMD).

These devices are intended for use in ophthalmic clinical settings and are supplied as reusable medical instruments. They are classified under Device Class II and comply with FDA 510(k) clearance, MDD, and MDR regulations. The Eidon series includes multiple models, each tailored for specific diagnostic applications, and must be operated by trained professionals in accordance with manufacturer instructions.

From the manufacturer

Manufacturer's product page: iCare EIDON

Devices cleared under K211328

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K211328
UDI-DISize and differences
EIDON UWF Module
CENTERVUE SPA
AXWFLME001 / EIDON UWF Module08053677040123 —On the market

Similar devices

Other devices filed under FDA product code MYC (Ophthalmoscope, Laser, Scanning).

Other devices from Centervue S.P.A.

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