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Unity 00380650003232

by Alcon Laboratories, Inc.

Ref 8065000323

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000070GY Basic UDI-DI 00380650003232UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380650003232 UDI-DI Date7 Apr 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Name
Anterior Segment Consumable Packs
Model / Ref / Catalog
8065000323, 00380650003232
Primary DI / UDI-DI
00380650003232
Basic UDI-DI
038065GMN000070GY
FDA Product Code
HQC
EMDN Code
Z1212020785 Phaco-vitrectomy instruments - consumables
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.4670
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
8065000323
GUDID
00380650003232
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

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

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No