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Clareon SY60WF

by Alcon Laboratories, Inc. 85 variants

Ref SY60WF.170

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

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 Number038065GMN000135H3 Basic UDI-DI 00380652251426UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380652251426 UDI-DI Date20 Oct 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0412 Withdrawn

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    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  • Withdrawn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 Aspheric IOL SY60WF
Model / reference
SY60WF.170 EUDAMED
SY60WF GUDID
Primary DI / UDI-DI
00380652251426
Basic UDI-DI
038065GMN000135H3
FDA product code
HQL
EMDN code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
GMDN term
Posterior-chamber intraocular lens, pseudophakic
Device class
Class IIb EUDAMED
Class III GUDID
Regulation number
886.3600
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
SY60WF.170
GUDID
SY60WF
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

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (19)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Sutures: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No