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Onefit MED MF Standard Optimum Infinite Ice blue

by Multilens AB 2 variants

Ref N20639Model Scleral and corneo-scleral RGP lenses, Optimum Infinite

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDR Number731686scleralOID3 Basic UDI-DI 07316860206395UDI-DIDate28 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Scleral and corneo-scleral RGP lenses, Optimum Infinite, N20639
Primary DI / UDI-DI
07316860206395
Basic UDI-DI
731686scleralOID3
EMDN Code
Q02100402 Contact lenses - non hydrogel
Device Class
Class IIa
Special Device Type
Made to order Rigid Gas Permeable (RGP) contact lenses
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000002792

Other devices from Multilens AB

See all devices from Multilens AB →

Properties

Other properties (13)

  • Sterile: No
  • 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