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IOT Neochromes HI 1.67 UC SFSV Brown 4

by Advanced Photochromics LLC United States EUDAMED

Ref 0265008540

EMDN Q0210010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081016109NeoChromesUB Basic UDI-DIDate9 Sep 2024RegisteredStatusActive

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
NeoChromes
Model / Reference
0265008540
Primary DI / UDI-DI
10810161090423
Basic UDI-DI
081016109NeoChromesUB
EMDN Code
Q0210010101 Monofocal organic ophthalmic lenses
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000043049
Authorised representative
INDIZEN OPTICAL TECHNOLOGIES S.L.U ES-AR-000042818

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 db1af060-d2f0-4c02-b4e9-4ad9acc6c1cb 61 fields · synced 22 Oct 2026