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Ocusan Single-Dose Eye Drops

by Agepha Pharma Slovakia EUDAMED

Ref 08588006940282

EMDN Q02030299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08588006940TD004XK Basic UDI-DIDate9 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ocusan
Model / Reference
08588006940282
Primary DI / UDI-DI
08588006940282
Basic UDI-DI
08588006940TD004XK
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 (12)
  • 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 3b81384f-c0a1-42fb-bbc7-912a740e9e9f 61 fields · synced 22 Oct 2026