Skip to content

EyeOn Air

by EyeTech Digital Systems United States EUDAMED

Ref EyeOn-12WC

EMDN Y214209,Y214212,Y214224,Y214299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B862EYEON12WCCN Basic UDI-DIDate16 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 Air
Model / Reference
EyeOn-12WC
Primary DI / UDI-DI
+B862EYEON12WC0/$2218F
Basic UDI-DI
++B862EYEON12WCCN
Direct Marketing DI
+B862EYEON12WC0/$2218F
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

From the manufacturer

Manufacturer's product page: EyeOn Air

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 (1)

  • EUDAMED 1520adbf-2c33-4574-adba-71506cec55bf 61 fields · synced 22 Oct 2026