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Fsv Omega Monofocal

by Μονοπροσωπη Ανωνυμη Βιομηχανικη Εμπορικη Εταιρια Οπτικων

Ref UO27464FOMModel FSV OMEGA MONOFOCAL

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-UO27464FOMW8 Basic UDI-DI D-UO27464FOMW8UDI-DIDate15 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Fsv Omega Monofocal Ophthalmic Lense
Model / Reference
FSV OMEGA MONOFOCAL, UO27464FOM
Primary DI / UDI-DI
D-UO27464FOMW8
Basic UDI-DI
B-UO27464FOMW8
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000027464

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No