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Edof 59

by mark'ennovy Personalized Care S.L. EUDAMED

Active European Union

Ref 30011, 30012, 20014Model Gentle Hydrogel Contact lenses, Silicone Hydrogel lathed contact lens

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  • Withdrawn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

Trade Name
Edof 59
EDOF 59 Toric
Edof
Device Name
Gentle Hydrogel Contact lenses
Silicone Hydrogel lathed contact lens
Model / Reference
Gentle Hydrogel Contact lenses, 30011, 30012, Silicone Hydrogel lathed contact lens, 20014
Primary DI / UDI-DI
08445773265294, 08445773265324, 08445773220194
Basic UDI-DI
8433108TF03-Gentle5C, 8433108TF02-SiliconeLMN
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.

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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