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Eye Mask/CE-Xxx

by Espansione Marketing SpA FDA registration: United States EUDAMED

Ref EYE MASK/CE-H05 EMDN Z12120199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08056389700286 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Accessories for devices with LED light technology (LLLT) for treatments in ophthalmology, dermatology and dental field
Model / Reference
EYE MASK/CE-H05
Primary DI / UDI-DI
08056389700286
Basic UDI-DI
B-08056389700286
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis 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 (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08056389700286|B-08056389700286 61 fields · synced 25 Oct 2026