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Ora System

by Alcon Laboratories, Inc. 2 variants

Ref 8065753002

Ora System (8065753002) is a medical equipment handle cover (EU MDR Class I; FDA Class II; FDA product code PUI, Drape, Surgical, Exempt) made by Alcon Laboratories, Inc., registered in EUDAMED on 6 May 2026 (Basic UDI-DI 038065GMN000225H5) and listed in FDA GUDID since 22 Jul 2026 (UDI-DI 00380657530021), 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
United StatesGUDID listing GUDID Number00380657530021 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number038065GMN000225H5 Basic UDI-DI 00380657530021UDI-DIDate6 May 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000225H5 registered 6 May 2026 Active
  • FDA GUDID UDI-DI 00380657530021 listed 22 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 038065GMN000225H5
  2. Listed FDA GUDID 00380657530021

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  • Withdrawn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
Ora System EUDAMED
ORA SYSTEM, VerifEye GUDID
Generic name
Medical equipment handle cover, reusable
Device name
ORA Autoclavable Cover
Model / reference
8065753002
Primary DI / UDI-DI
00380657530021
Basic UDI-DI
038065GMN000225H5
FDA product code
PUI
EMDN code
Z12120180 Ophtalmology assessments and diagnosis instruments - hardware accessories
GMDN term
Medical equipment handle cover, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000016248
Authorised representative
Alcon Laboratories Belgium BE-AR-000014721

Similar devices in this category

Other devices filed under OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)