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S-Maia

by Centervue S.P.A.

Ref ACMASME002

S-Maia (ACMASME002) is a perimeter (EU MDD Class IIa; FDA Class I; FDA product code HPT, Perimeter, Automatic, Ac-Powered) made by Centervue S.P.A., registered in EUDAMED on 29 Nov 2021 (Basic UDI-DI B-08053677040055), cleared under FDA 510(k) K153181 on 8 Jun 2016 and listed in FDA GUDID since 3 Aug 2016 (UDI-DI 08053677040055), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153181↗

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/MDD EUDAMED NumberB-08053677040055 Basic UDI-DI 08053677040055UDI-DIDate29 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08053677040055 UDI-DI Date3 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK153181 Date8 Jun 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08053677040055 registered 29 Nov 2021 Active
  • FDA 510(k) K153181 decided 8 Jun 2016 Active
  • FDA GUDID UDI-DI 08053677040055 listed 3 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153181
  2. Listed FDA GUDID 08053677040055
  3. Registered EUDAMED B-08053677040055

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  • Withdrawn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
Maia
Generic name
Perimeter, automatic
Device name
S-Maia
Model / Ref / Catalog
ACMASME002, S-MAIA
Primary DI / UDI-DI
08053677040055
Basic UDI-DI
B-08053677040055
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
ACMASME002
GUDID
S-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)