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Clareon Vivity Toric Extended Vision UV Absorbing IOLs with the AutonoMe CCAET4

by Alcon Laboratories, Inc. 31 variants

Ref CCAET4.125

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

1 certificate

Certifier TÜV SÜD Product Service GmbH

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 Number038065GMN000249HK Basic UDI-DI 00380652451246UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380652451246 UDI-DI Date10 Mar 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0414 Withdrawn

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    11 Jun 2026
    Expires
    20 Jan 2030
    Reason
    Transferred to other nb

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  • Withdrawn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
Clareon Vivity, AutonoMe EUDAMED
Clareon Vivity Toric Extended Vision UV Absorbing IOLs with the AutonoMe GUDID
Generic Name
Posterior-chamber intraocular lens, pseudophakic
Device Name
Clareon Vivity Toric Extended Vision UV Absorbing IOLs with the AutonoMe Automated Pre loaded Delivery System
Model / Ref / Catalog
CCAET4.125, CCAET4
Primary DI / UDI-DI
00380652451246
Basic UDI-DI
038065GMN000249HK
FDA Product Code
POE
EMDN Code
P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
GMDN Term
Posterior-chamber intraocular lens, pseudophakic
Device Class
Class IIb EUDAMED
Class III GUDID
Regulation Number
886.3600
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CCAET4.125
GUDID
CCAET4
Device ClassEUDAMED
Class IIb
GUDID
Class III

Related devices

Category: Posterior-chamber intraocular lens, pseudophakic

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Animal Tissues
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human 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