EIDON UWF Module

Ref AXWFLME001

EIDON UWF Module (AXWFLME001) is an ophthalmic fundus camera (EU MDR Class I; 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 805367704EIDON-UWFDW), cleared under FDA 510(k) K211328 on 19 Aug 2021 and listed in FDA GUDID since 29 Apr 2026 (UDI-DI 08053677040123), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211328

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number08053677040123 UDI-DI	Date29 Apr 2026Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number805367704EIDON-UWFDW Basic UDI-DI 08053677040123UDI-DI	Date26 Nov 2021Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK211328	Date19 Aug 2021Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 805367704EIDON-UWFDW — open Devices and search for it
AccessGUDID record UDI-DI 08053677040123
FDA 510(k) database 510(k) number K211328

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 805367704EIDON-UWFDW registered 26 Nov 2021 Active
FDA 510(k) K211328 decided 19 Aug 2021 Active
FDA GUDID UDI-DI 08053677040123 listed 29 Apr 2026 Listed

Timeline

3 dated events

19 Aug 2021 Cleared FDA 510(k) K211328
26 Nov 2021 Registered EUDAMED 805367704EIDON-UWFDW
29 Apr 2026 Listed FDA GUDID 08053677040123

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Eidon
Generic name: Ophthalmic fundus camera
Model / Ref / Catalog: AXWFLME001, EIDON UWF Module

Primary DI / UDI-DI: 08053677040123
Basic UDI-DI: 805367704EIDON-UWFDW
Direct marketing DI: 08053677040123
510(k) Number: K211328
FDA product code: MYC
EMDN code: Z12120180 Ophtalmology assessments and diagnosis instruments - hardware accessories
GMDN term: Ophthalmic fundus camera

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 886.1570
EU registration type: Standard device
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED AXWFLME001	GUDID EIDON UWF Module
Device class	EUDAMED 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: IT-MF-000017082

Similar devices in this category

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Properties

Prescription use
Lot / batch number
Serial number
Manufacturing date

Other properties (21, all answered No)