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Oftalergin krople®

by bitop AG Germany EUDAMED

Ref 38128Model AAT04 EMDN Q02030299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-38128H2 Basic UDI-DIDate9 Jan 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  • Withdrawn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 22 Oct 2026

Device Name
Ectoin® Allergy Eye Drops 2%
Model / Reference
AAT04, 38128
Primary DI / UDI-DI
D-38128H2
Basic UDI-DI
B-38128H2
EMDN Code
Q02030299 Ophthalmology, liquid fluids - other
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
DE-MF-000006543

Other devices from bitop AG

See all devices from bitop AG →

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 32bc728f-c6a7-4c1d-bf0d-b1ecbf033fd3 61 fields · synced 22 Oct 2026