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RETIA2

by Centervue S.P.A.

Ref AINEUME002

RETIA2 (AINEUME002) is an ophthalmic fundus camera (EU MDD Class IIa; FDA Class II; FDA product code MYC, Ophthalmoscope, Laser, Scanning) made by Centervue S.P.A., registered in EUDAMED on 29 Nov 2021 (Basic UDI-DI B-08053677040086), cleared under FDA 510(k) K180293 on 30 May 2018 and listed in FDA GUDID since 15 Jul 2017 (UDI-DI 08053677040086), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180293↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08053677040086 Basic UDI-DI 08053677040086UDI-DIDate29 Nov 2021RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK180293 Date30 May 2018IssuedStatusActive
United StatesGUDID listing GUDID Number08053677040086 UDI-DI Date15 Jul 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08053677040086 registered 29 Nov 2021 Active
  • FDA 510(k) K180293 decided 30 May 2018 Active
  • FDA GUDID UDI-DI 08053677040086 listed 15 Jul 2017 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 08053677040086
  2. Cleared FDA 510(k) K180293
  3. Registered EUDAMED B-08053677040086

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Retia 2
Generic name
Ophthalmic fundus camera
Device name
RETIA2
Model / Ref / Catalog
AINEUME002, RETIA 2
Primary DI / UDI-DI
08053677040086
Basic UDI-DI
B-08053677040086
510(k) Number
FDA product code
MYC
EMDN code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
GMDN term
Ophthalmic fundus camera
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1570
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AINEUME002
GUDID
RETIA 2
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
  • Manufacturing date
Other properties (19, all answered No)