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iCare MAIA

by Centervue S.P.A.

Ref AHMACME001

iCare MAIA (AHMACME001) is a device classified as Class IIa in the EU and Class II in the US made by Centervue S.P.A., registered in EUDAMED on 1 Apr 2025 (Basic UDI-DI 805367704MicroPerimeterRM), cleared under FDA 510(k) K243504 on 17 Mar 2025 and listed in FDA GUDID since 29 Apr 2026 (UDI-DI 08053677040130), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243504↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08053677040130 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805367704MicroPerimeterRM Basic UDI-DI 08053677040130UDI-DIDate1 Apr 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK243504 Date17 Mar 2025IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805367704MicroPerimeterRM registered 1 Apr 2025 Active
  • FDA 510(k) K243504 decided 17 Mar 2025 Active
  • FDA GUDID UDI-DI 08053677040130 listed 29 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243504
  2. Registered EUDAMED 805367704MicroPerimeterRM
  3. Listed FDA GUDID 08053677040130

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
iCare MAIA EUDAMED
Maia GUDID
Generic name
Perimeter, automatic
Model / Ref / Catalog
AHMACME001, MAIA3
Primary DI / UDI-DI
08053677040130
Basic UDI-DI
805367704MicroPerimeterRM
Direct marketing DI
08053677040130
510(k) Number
FDA product code
MYC
EMDN code
Z1212012003 Peripheral vision analysers
GMDN term
Perimeter, automatic
Device class
Class IIa 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

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AHMACME001
GUDID
MAIA3
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

From the manufacturer

Manufacturer's product page: iCare MAIA

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
  • Manufacturing date
Other properties (21, all answered No)