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Alcon 8065421020

by Alcon Laboratories, Inc.

Ref 8065421020

Alcon 8065421020 is a device classified as Class IIa in the EU and Class I in the US made by Alcon Laboratories, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 038065GMN000042GT) and listed in FDA GUDID since 18 Aug 2020 (UDI-DI 00380654210209), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000042GT Basic UDI-DI 00380654210209UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380654210209 UDI-DI Date18 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000042GT registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00380654210209 listed 18 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380654210209
  2. Registered EUDAMED 038065GMN000042GT

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  • Withdrawn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
Alcon
Generic name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device name
Cannulas and Cystitomes – Needles
Model / reference
8065421020
Primary DI / UDI-DI
00380654210209
Basic UDI-DI
038065GMN000042GT
FDA product code
HNY
EMDN code
Q021101 Occular irrigation and aspiration cannulas, single-use
GMDN term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4350
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Similar devices in this category

Other devices filed under OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE.

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
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)