Skip to content

Leo-Plus Sheet Frame

by New Optics India EUDAMED

Ref LeoPlus Sht Fr-002

EMDN Q02100202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890621144LEOPLSHTFRJ5 Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Leo Plus Sheet Frame
Model / Reference
LeoPlus Sht Fr-002
Primary DI / UDI-DI
08906211440050
Basic UDI-DI
890621144LEOPLSHTFRJ5
EMDN Code
Q02100202 Plastic spectacle frames without lenses
Device Class
Class I
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
IN-MF-000051780
Authorised representative
New Optics OÜ EE-AR-000051221

Other devices from New Optics

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED aec97cf3-7116-4b51-b03b-0e9ae74c66d6 61 fields · synced 24 Oct 2026