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Tek-Lens II

by Tekia, Inc. United States EUDAMED

Ref 618Y

EMDN P030102090202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-++M519TEK01358 Basic UDI-DIDate2 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hydrophilic Acrylic Intraocular lens
Model / Reference
618Y
Primary DI / UDI-DI
++M519TEK01358
Basic UDI-DI
B-++M519TEK01358
EMDN Code
P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000020955
Authorised representative
CALICEOS FR-AR-000009387

Other devices from Tekia, Inc.

See all devices from Tekia, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0c9d51c4-bde2-496e-b907-025d078d4760 61 fields · synced 22 Oct 2026