Skip to content

Eye Mask

by Espansione Marketing SpA 7 variants

Ref EYE MASK/CE-HB0250

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80563897MASKZONE0000FG Basic UDI-DI 08056389702457UDI-DIDate29 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Accessory of device for phototherapy in ophthalmology
Model / Reference
EYE MASK/CE-HB0250
Primary DI / UDI-DI
08056389702457
Basic UDI-DI
80563897MASKZONE0000FG
EMDN Code
Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
Device Class
Class IIa
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
IT-MF-000027514

Other devices from Espansione Marketing SpA

See all devices from Espansione Marketing SpA →

Properties

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