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Xtensa SiHy SPH 6pk

by mark'ennovy Personalized Care S.L. EUDAMED

Active European Union

Ref 50001Model 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  • Withdrawn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

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
Silicone Hydrogel moulded contact lens
Model / Reference
Silicone Hydrogel moulded contact lens, 50001
Primary DI / UDI-DI
84457735F15650001MGJA
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