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Alcon 00380650003935

by Alcon Laboratories, Inc.

Ref 8065000393

Alcon 00380650003935 is an ophthalmic surgical procedure kit (EU MDR Class IIa; FDA Class II; FDA product code HQE, Instrument, Vitreous Aspiration And Cutting, Ac-Powered) made by Alcon Laboratories, Inc., registered in EUDAMED on 8 Jan 2026 (Basic UDI-DI 038065GMN000202GR) and listed in FDA GUDID since 2 Jul 2024 (UDI-DI 00380650003935), 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 Number038065GMN000202GR Basic UDI-DI 00380650003935UDI-DIDate8 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380650003935 UDI-DI Date2 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000202GR registered 8 Jan 2026 Active
  • FDA GUDID UDI-DI 00380650003935 listed 2 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380650003935
  2. Registered EUDAMED 038065GMN000202GR

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  • Withdrawn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
Unity EUDAMED
Alcon GUDID
Generic name
Ophthalmic surgical procedure kit, non-medicated, single-use
Device name
Viscous Fluid Control (VFC) Pak
Model / Ref / Catalog
8065000393, 00380650003935
Primary DI / UDI-DI
00380650003935
Basic UDI-DI
038065GMN000202GR
FDA product code
HQE
EMDN code
Z12120285 Therapeutic and surgical ophtholmological treatments instruments - consumables
GMDN term
Ophthalmic surgical procedure kit, non-medicated, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.4150
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8065000393
GUDID
00380650003935
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

Similar devices in this category

Other devices filed under THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES.

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)