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Blue Cut

by New Optics India EUDAMED

Ref 10011

EMDN Q0210010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890621144161BCFSVV4 Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Blue Cut Single Vision Ophthalmic Lens
Model / Reference
10011
Primary DI / UDI-DI
08906211440005
Basic UDI-DI
890621144161BCFSVV4
EMDN Code
Q0210010101 Monofocal organic ophthalmic 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 3e6e65ec-ac4f-46c3-852e-c184aec3599d 61 fields · synced 22 Oct 2026