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prescription ophtalmic lenses

by SANI GROUP d.o.o. EUDAMED

Active European Union

Ref clear indeks 1.5Model clear indeks 1.5,1.53,1.6,1.67,1.74: single vision,bitocal,progressive Uncoated,Hard-coated,Anti-reflex- coated photochromic indeks 1.5, etc

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8606113110LensesSH Basic UDI-DIDate3 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
prescription ophtalmic lenses
Model / Reference
clear indeks 1.5, 1.53, 1.6, 1.67, 1.74: single vision, bitocal, progressive Uncoated, Hard-coated, Anti-reflex- coated photochromic indeks 1.5, etc
Primary DI / UDI-DI
08606113110005
Basic UDI-DI
8606113110LensesSH
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
RS-MF-000048277
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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