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EyeOn Elite

by EyeTech Digital Systems United States EUDAMED

Ref EyeOn-14WE

EMDN Y214209,Y214212,Y214224,Y214299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B862EYEON14WED4 Basic UDI-DIDate15 May 2023RegisteredStatusActive

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
EyeOn Elite
Model / Reference
EyeOn-14WE
Primary DI / UDI-DI
*+B862EYEON14WE0/$2136I*, +B862EYEON14WE0D
Basic UDI-DI
++B862EYEON14WED4
Direct Marketing DI
*+B862EYEON14WE0/$2136I*
+B862EYEON14WE0D
EMDN Code
Y214209,Y214212,Y214224,Y214299
Device Class
Class I
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000035001
Authorised representative
EyeTech Europe B.V. NL-AR-000023070

Other devices from EyeTech Digital Systems

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 (2)

  • EUDAMED e7ba1681-489d-45d7-90b5-c2e32327b399 61 fields · synced 22 Oct 2026
  • EUDAMED 6140d727-0775-4d5a-a4df-e9a2a42d5cac 61 fields · synced 17 May 2026