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Smartfield

by OCULUS Optikgeräte GmbH

Ref 14000

Smartfield (14000) is a Class I device made by OCULUS Optikgeräte GmbH, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 40495842BC) and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 04049584019363), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40495842BC Basic UDI-DI 04049584019363UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584019363 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40495842BC registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 04049584019363 listed 30 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049584019363
  2. Registered EUDAMED 40495842BC

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Perimeter, automatic
Model / reference
14000
Primary DI / UDI-DI
04049584019363
Basic UDI-DI
40495842BC
FDA product code
HPT, HOO
EMDN code
Z1212012003 Peripheral vision analysers
GMDN term
Perimeter, automatic
Device class
Class I
Regulation number
886.1605
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000012227

Related devices

Category: Perimeter, automatic

Similar devices in this category

Other devices filed under PERIPHERAL VISION ANALYSERS.

Other devices from OCULUS Optikgeräte GmbH

See all devices from OCULUS Optikgeräte GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)