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Filcon 2 (30) 59% Sph

by mark'ennovy Personalized Care S.L. EUDAMED

Active European Union

Ref 08445773221023Model Gentle Hydrogel Contact lenses

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8433108TF03-Gentle5C Basic UDI-DIDate23 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Gentle Hydrogel Contact lenses
Model / Reference
Gentle Hydrogel Contact lenses, 08445773221023
Primary DI / UDI-DI
08445773221023
Basic UDI-DI
8433108TF03-Gentle5C
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Made to order soft contact lenses
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001436

Other devices from mark'ennovy Personalized Care S.L.

See all devices from mark'ennovy Personalized Care S.L. →

Properties

  • Sterile

Other properties (12)

  • 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