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Eyevan

by EYEVAN Inc. 205 variants

Part of a family of 36 devices: see the family page

Ref OPTIMO 46 SMKModel Plastic

Eyevan (OPTIMO 46 SMK) is a Class I device made by Eyevan Inc., registered in EUDAMED on 5 Jun 2024 (Basic UDI-DI 458266900RXPLANY), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number458266900RXPLANY Basic UDI-DI 04582669001698UDI-DIDate5 Jun 2024RegisteredStatusActive

Official records

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device name
Plastic spectacle frames without lenses
Model / reference
Plastic, OPTIMO 46 SMK
Primary DI / UDI-DI
04582669001698
Basic UDI-DI
458266900RXPLANY
EMDN code
Q02100202 Plastic spectacle frames without lenses
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
JP-MF-000028437
Authorised representative
EYEVAN Europe FR-AR-000025678

Similar devices in this category

Other devices filed under CORRECTIVE OPTICAL DEVICES.

Other devices from Eyevan Inc.

See all devices from Eyevan Inc. →

Properties

Other properties (14, all answered No)