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Insight by mark'ennovy SPH 6pk

by mark'ennovy Personalized Care S.L. EUDAMED

Active European Union

Ref 50007Model Silicone Hydrogel moulded contact lens

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8433108TF05-SiliconeMmEV Basic UDI-DIDate11 May 2026RegisteredStatusActive

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  • Withdrawn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
Silicone Hydrogel moulded contact lens
Model / Reference
Silicone Hydrogel moulded contact lens, 50007
Primary DI / UDI-DI
84457735F15650007MGK8
Basic UDI-DI
8433108TF05-SiliconeMmEV
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Standard 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