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Maia

by Centervue S.P.A.

Ref ATMARME002

Maia (ATMARME002) is a device classified as Class IIa in the EU and Class I in the US made by Centervue S.P.A., registered in EUDAMED on 29 Nov 2021 (Basic UDI-DI B-08053677040024), cleared under FDA 510(k) K153181 on 8 Jun 2016 and listed in FDA GUDID since 29 Jul 2016 (UDI-DI 08053677040024), 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) K153181

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-08053677040024 Basic UDI-DI 08053677040024UDI-DIDate29 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08053677040024 UDI-DI Date29 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK153181 Date8 Jun 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08053677040024 registered 29 Nov 2021 Active
  • FDA 510(k) K153181 decided 8 Jun 2016 Active
  • FDA GUDID UDI-DI 08053677040024 listed 29 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153181
  2. Listed FDA GUDID 08053677040024
  3. Registered EUDAMED B-08053677040024

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  • Withdrawn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
Perimeter, automatic
Model / Ref / Catalog
ATMARME002, MAIA
Primary DI / UDI-DI
08053677040024
Basic UDI-DI
B-08053677040024
510(k) Number
FDA product code
HPT
EMDN code
Z1212012003 Peripheral vision analysers
GMDN term
Perimeter, automatic
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.1605
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ATMARME002
GUDID
MAIA
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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

Related devices

Category: Perimeter, automatic

Similar devices in this category

Other devices filed under PERIPHERAL VISION ANALYSERS.

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 (20, all answered No)