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Alcon 00380650003591

by Alcon Laboratories, Inc.

Part of a family of 21 devices: see the family page

Ref 8065000359

Alcon 00380650003591 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 30 Oct 2026 (Basic UDI-DI 038065GMN000211GS) and listed in FDA GUDID since 8 Apr 2025 (UDI-DI 00380650003591), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000211GS Basic UDI-DI 00380650003591UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380650003591 UDI-DI Date8 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038065GMN000211GS registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00380650003591 listed 8 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380650003591
  2. Registered EUDAMED 038065GMN000211GS

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  • Withdrawn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 cannulation set, single-use
Device name
Non-Valved Entry Systems
Model / Ref / Catalog
8065000359, 00380650003591
Primary DI / UDI-DI
00380650003591
Basic UDI-DI
038065GMN000211GS
FDA product code
NGY
EMDN code
Z1212020785 Phaco-vitrectomy instruments - consumables
GMDN term
Ophthalmic cannulation set, 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8065000359
GUDID
00380650003591
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 cannulation set, single-use

Similar devices in this category

Other devices filed under PHACO-VITRECTOMY 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)