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AcrySof

by Alcon Laboratories, Inc. 299 variants

Ref DFT215-105

Active European Union

CE MDR

Valid until

29 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberG70 020895 0397 Date11 Jun 2026IssuedStatusActive expires 29 Aug 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 020895 0397 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    11 Jun 2026
    Expires
    29 Aug 2028
    Reason
    Add device or group

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
AcrySof IQ Vivity Toric Extended Vision IOLs
Model / Reference
DFT215-105
Primary DI / UDI-DI
00380658420604
Basic UDI-DI
038065GMN000134GZ
EMDN Code
P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016248
Authorised representative
Alcon Laboratories Belgium BE-AR-000014721

Other devices from Alcon Laboratories, Inc.

See all devices from Alcon Laboratories, Inc. →

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No