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ICL/TICL Calculation / Implantation Orientation Diagram (IOD) Software

by STAAR Surgical AG

Ref ICL/TICL Calculation / Implantation Orientation Diagram (IOD) Software

Expiring European Union

CE MDR

Valid until

15 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08415421OCOSJZ Basic UDI-DI 00840311346271UDI-DIDate12 May 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
ICL/TICL Calculation Software
Model / Reference
ICL/TICL Calculation / Implantation Orientation Diagram (IOD) Software
Primary DI / UDI-DI
00840311346271
Basic UDI-DI
08415421OCOSJZ
EMDN Code
Z12129082 Various ophtalmology instruments - software accessories
Device Class
Class IIa
Special Device Type
Software
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

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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