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Twinfield 3

by OCULUS Optikgeräte GmbH

Ref 10034819

Twinfield 3 (10034819) is a Class I device made by OCULUS Optikgeräte GmbH, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 40495845BJ) and listed in FDA GUDID since 14 Jan 2026 (UDI-DI 04049584037251), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40495845BJ Basic UDI-DI 04049584037251UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584037251 UDI-DI Date14 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40495845BJ registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 04049584037251 listed 14 Jan 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049584037251
  2. Registered EUDAMED 40495845BJ

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  • Withdrawn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
Device name
Twinfield
Model / reference
10034819
Primary DI / UDI-DI
04049584037251
Basic UDI-DI
40495845BJ
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

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)