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Clareon CCA0T5

by Alcon Laboratories, Inc. 29 variants

Ref CCA0T5.175

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038065GMN000141GW Basic UDI-DI 00380652442381UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380652442381 UDI-DI Date21 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0412 Withdrawn

    Technical documentation EU MDR

    Issued
    11 Jun 2026
    Expires
    4 Dec 2029
    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  • Withdrawn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
Generic Name
Posterior-chamber intraocular lens, pseudophakic
Device Name
Clareon Toric Aspheric IOL AutonoMe Pre-Loaded Delivery System CCA0T2-CCA0T9
Model / Ref / Catalog
CCA0T5.175, CCA0T5
Primary DI / UDI-DI
00380652442381
Basic UDI-DI
038065GMN000141GW
FDA Product Code
HQL
EMDN Code
P030102090301 IOLs, APHAKIC, MONOFOCAL, 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
CCA0T5.175
GUDID
CCA0T5
Device ClassEUDAMED
Class IIb
GUDID
Class III

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