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EVO+ Visian Toric ICL

by STAAR Surgical AG 742 variants

Ref VTICM5 12.1

Expiring European Union

CE MDR

Valid until

15 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3830100TD01 Date29 Jul 2025IssuedStatusExpiring expires 15 Jul 2027

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 3830100CE01 Expiring Amended Expires in 257 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Aug 2024
    Expires
    15 Jul 2027
    Reason
    Mnf ar change
  • 3830100TD01 Expiring Amended Expires in 257 days

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    29 Jul 2025
    Expires
    15 Jul 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Implantable Collamer Lens
Model / Reference
VTICM5 12.1
Primary DI / UDI-DI
00840311306848, 00840311304578, 00840311307142
Basic UDI-DI
764013516ICLGV
EMDN Code
P030101030399 IOLs, PHAKIC, MONOFOCAL, TORIC - OTHER
Device Class
Class III
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CH-MF-000039544
Authorised representative
STAAR Surgical AG ES-AR-000025479

Other devices from STAAR Surgical AG

See all devices from STAAR Surgical AG →

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

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