Skip to content

iGel Eye Drops

by Agepha Pharma Slovakia EUDAMED

Ref 09003585000275

EMDN Q02030299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09003585000275 Basic UDI-DIDate9 Apr 2025RegisteredStatusActive

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
09003585000275
Primary DI / UDI-DI
09003585000275
Basic UDI-DI
B-09003585000275
EMDN Code
Q02030299 Ophthalmology, liquid fluids - other
Device Class
Class IIb
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
SK-MF-000018617

Other devices from Agepha Pharma

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 (1)

  • EUDAMED 9385d59b-552a-4f22-8f35-99ced616bae3 61 fields · synced 22 Oct 2026