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Easyfield S

by OCULUS Optikgeräte GmbH

Ref 15005

Easyfield S (15005) is a Class I device made by OCULUS Optikgeräte GmbH, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 40495844BG) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 04049584000064), 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 Number40495844BG Basic UDI-DI 04049584000064UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584000064 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40495844BG registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 04049584000064 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049584000064
  2. Registered EUDAMED 40495844BG

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  • Withdrawn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
15005
Primary DI / UDI-DI
04049584000064
Basic UDI-DI
40495844BG
FDA product code
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
Size
Weight — 4.6 Kilogram
Height — 435 Millimeter
Depth — 450 Millimeter
Width — 275 Millimeter

Manufacturer details

EUDAMED SRN
DE-MF-000012227

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
Other properties (22, all answered No)