Skip to content

Eye Mask

by Espansione Marketing SpA United States EUDAMED

Ref EYE MASK/CE-HY0250 EMDN Z12120299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80563897MASKZONE0000FG Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Accessory of device for phototherapy in ophthalmology
Model / Reference
EYE MASK/CE-HY0250
Primary DI / UDI-DI
08056389702501
Basic UDI-DI
80563897MASKZONE0000FG
EMDN Code
Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
IT-MF-000027514

Other devices from Espansione Marketing SpA

See all devices from Espansione Marketing SpA →

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 67ad9a49-a4da-4ce7-b196-d2cea2110d99 61 fields · synced 25 Oct 2026