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by iVis Technologies S.r.l. Italy EUDAMED

Ref OX0001, OX0002

EMDN Q02030299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08055384200005 Basic UDI-DIDate9 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
OX0001, OX0002
Primary DI / UDI-DI
08055384200005, 08055384200012
Basic UDI-DI
B-08055384200005, B-08055384200012
EMDN Code
Q02030299 Ophthalmology, liquid fluids - other
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000016859

Other devices from iVis Technologies S.r.l.

See all devices from iVis Technologies S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • 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 (2)

  • EUDAMED f24a042d-2d78-43c5-9391-4eaae58cde30 61 fields · synced 22 Oct 2026
  • EUDAMED 08055384200012|B-08055384200012 61 fields · synced 18 May 2026