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Ocea

by Lentilles France EUDAMED

Ref MANYModel STERILE SOFT CONTACT LENS

EMDN Q0210040102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFR26/0000004 Date11 May 2026IssuedStatusActive expires 13 Jan 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FR26/0000004 Amended

    Quality assurance EU MDR

    Notified body
    Notified body 1639
    Issued
    11 May 2026
    Expires
    13 Jan 2031
    Reason
    Mnf ar change

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
STERILE SOFT CONTACT LENS, MANY
Primary DI / UDI-DI
13664043000287
Basic UDI-DI
36640434BC
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
Device Class
Class IIa
Special Device Type
Made to order soft contact lenses
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000006721

Other devices from Lentilles

See all devices from Lentilles →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED da9be54e-9082-40e3-a723-75f300176bcb 61 fields · synced 22 Oct 2026