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Binoptometer 4P

by OCULUS Optikgeräte GmbH 2 variants

Ref 59860

Binoptometer 4P (59860) is a Class I device made by OCULUS Optikgeräte GmbH, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 404958410PL) and listed in FDA GUDID since 1 Dec 2022 (UDI-DI 04049584010032), 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 Number404958410PL Basic UDI-DI 04049584010032UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584010032 UDI-DI Date1 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 404958410PL registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 04049584010032 listed 1 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049584010032
  2. Registered EUDAMED 404958410PL

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  • Withdrawn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

Trade name
Binoptometer 4P EUDAMED
Binoptometer® 4P incl. integrated electromotoric height adjustment GUDID
Generic name
Binocular vision test unit
Model / reference
59860
Primary DI / UDI-DI
04049584010032
Basic UDI-DI
404958410PL
FDA product code
HJQ, HOX
EMDN code
Z1212012001 Visual functional assessment equipment
GMDN term
Binocular vision test unit
Device class
Class I
Regulation number
886.1870, 886.1150
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000012227

Similar devices in this category

Other devices filed under VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT.

Other devices from OCULUS Optikgeräte GmbH

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Properties

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