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Compass

by Centervue S.P.A.

Ref AMGSDME001

Compass (AMGSDME001) 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 28 Oct 2024 (Basic UDI-DI 805367704PerimeterV7), cleared under FDA 510(k) K150320 on 30 Jun 2015 and listed in FDA GUDID since 3 Aug 2016 (UDI-DI 08053677040048), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150320↗

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/MDR EUDAMED Number805367704PerimeterV7 Basic UDI-DI 08053677040048UDI-DIDate28 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08053677040048 UDI-DI Date3 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK150320 Date30 Jun 2015IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 805367704PerimeterV7 registered 28 Oct 2024 Active
  • FDA 510(k) K150320 decided 30 Jun 2015 Active
  • FDA GUDID UDI-DI 08053677040048 listed 3 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150320
  2. Listed FDA GUDID 08053677040048
  3. Registered EUDAMED 805367704PerimeterV7

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  • Withdrawn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

Generic name
Perimeter, automatic
Model / Ref / Catalog
AMGSDME001 EUDAMED
COMPASS GUDID
AMGSDME01 GUDID
Primary DI / UDI-DI
08053677040048
Basic UDI-DI
805367704PerimeterV7, B-08053677040048
Direct marketing DI
08053677040048
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
Standard device
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
AMGSDME001
GUDID
COMPASS
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 (22, all answered No)