Skip to content

EVO+ Visian Toric ICL

by STAAR Surgical AG Switzerland EUDAMED

Ref VTICM5 12.1 EMDN P030101030399

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 3830100CE01 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    15 Aug 2024
    Expires
    15 Jul 2027
    Reason
    Mnf ar change
  • 3830100TD01 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    29 Jul 2025
    Expires
    15 Jul 2027
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Implantable Collamer Lens
Model / Reference
VTICM5 12.1
Primary DI / UDI-DI
00840311306497, 00840311304868, 00840311304851, 00840311305445, 00840311306909, 00840311306640, 00840311306947, 00840311304325, 00840311306596, 00840311306886, 00840311307333, 00840311306572, 00840311305704, 00840311306336, 00840311306916, 00840311306329, 00840311305964, 00840311306701, 00840311305742, 00840311305988, 00840311304295, 00840311305674, 00840311304585, 00840311306534, 00840311304103, 00840311306817, 00840311307241, 00840311306374, 00840311305162, 00840311307197, 00840311304615, 00840311307296, 00840311307005, 00840311306527, 00840311306992, 00840311306237, 00840311306039, 00840311305131, 00840311307234, 00840311305681, 00840311306930, 00840311306985, 00840311304301, 00840311307104, 00840311306381, 00840311303991, 00840311306978, 00840311307258, 00840311306602, 00840311306671
Basic UDI-DI
764013516ICLGV
EMDN Code
P030101030399 IOLs, PHAKIC, MONOFOCAL, TORIC - OTHER
Device Class
Class III
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (50)

  • EUDAMED 23a508ba-a91c-486e-83f0-c935c02f5838 61 fields · synced 24 Oct 2026
  • EUDAMED 00840311304868|764013516ICLGV 61 fields · synced 7 Oct 2026
  • EUDAMED 00840311304851|764013516ICLGV 61 fields · synced 7 Oct 2026
  • EUDAMED 00840311305445|764013516ICLGV 61 fields · synced 7 Oct 2026
  • EUDAMED 00840311306909|764013516ICLGV 61 fields · synced 7 Oct 2026
  • EUDAMED 00840311306640|764013516ICLGV 61 fields · synced 7 Oct 2026
  • EUDAMED 00840311306947|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311304325|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311306596|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311306886|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311307333|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311306572|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311305704|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311306336|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311306916|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311306329|764013516ICLGV 61 fields · synced 8 Oct 2026
  • EUDAMED 00840311305964|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311306701|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311305742|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311305988|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311304295|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311305674|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311304585|764013516ICLGV 61 fields · synced 9 Oct 2026
  • EUDAMED 00840311306534|764013516ICLGV 61 fields · synced 10 Oct 2026
  • EUDAMED 00840311304103|764013516ICLGV 61 fields · synced 10 Oct 2026
  • EUDAMED 00840311306817|764013516ICLGV 61 fields · synced 10 Oct 2026
  • EUDAMED 00840311307241|764013516ICLGV 61 fields · synced 10 Oct 2026
  • EUDAMED 00840311306374|764013516ICLGV 61 fields · synced 10 Oct 2026
  • EUDAMED 00840311305162|764013516ICLGV 61 fields · synced 11 Oct 2026
  • EUDAMED 00840311307197|764013516ICLGV 61 fields · synced 11 Oct 2026
  • EUDAMED 00840311304615|764013516ICLGV 61 fields · synced 11 Oct 2026
  • EUDAMED 00840311307296|764013516ICLGV 61 fields · synced 11 Oct 2026
  • EUDAMED 00840311307005|764013516ICLGV 61 fields · synced 13 Oct 2026
  • EUDAMED 00840311306527|764013516ICLGV 61 fields · synced 13 Oct 2026
  • EUDAMED 00840311306992|764013516ICLGV 61 fields · synced 13 Oct 2026
  • EUDAMED 00840311306237|764013516ICLGV 61 fields · synced 13 Oct 2026
  • EUDAMED 00840311306039|764013516ICLGV 61 fields · synced 14 Oct 2026
  • EUDAMED 00840311305131|764013516ICLGV 61 fields · synced 14 Oct 2026
  • EUDAMED 00840311307234|764013516ICLGV 61 fields · synced 14 Oct 2026
  • EUDAMED 00840311305681|764013516ICLGV 61 fields · synced 14 Oct 2026
  • EUDAMED 00840311306930|764013516ICLGV 61 fields · synced 14 Oct 2026
  • EUDAMED 00840311306985|764013516ICLGV 61 fields · synced 14 Oct 2026
  • EUDAMED 00840311304301|764013516ICLGV 61 fields · synced 15 Oct 2026
  • EUDAMED 00840311307104|764013516ICLGV 61 fields · synced 15 Oct 2026
  • EUDAMED 00840311306381|764013516ICLGV 61 fields · synced 15 Oct 2026
  • EUDAMED 00840311303991|764013516ICLGV 61 fields · synced 16 Oct 2026
  • EUDAMED 00840311306978|764013516ICLGV 61 fields · synced 16 Oct 2026
  • EUDAMED 00840311307258|764013516ICLGV 61 fields · synced 17 Oct 2026
  • EUDAMED 00840311306602|764013516ICLGV 61 fields · synced 17 Oct 2026
  • EUDAMED 00840311306671|764013516ICLGV 61 fields · synced 19 Oct 2026