Skip to content

omafilcon A sphere Daily Disposal Contact Lenses

by CooperVision Manufacturing Limited EUDAMED

Active European Union

Ref many

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0196126LENS026LH Basic UDI-DIDate1 Jul 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  • Withdrawn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
omafilcon A sphere Daily Disposal Contact Lenses
Model / Reference
many
Primary DI / UDI-DI
0196126A9NC
Basic UDI-DI
0196126LENS026LH
EMDN Code
Q021004010101 Contact lenses - hydrogel, daily single-use
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
GB-MF-000021104
Authorised representative
CooperVision CL Kft. HU-AR-000020102

Other devices from CooperVision Manufacturing Ltd

See all devices from CooperVision Manufacturing Ltd →

Properties

Show 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