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BIOLAN® gel

by Penta Arzneimittel GmbH Germany EUDAMED

Ref 41019300LModel Moisturizing Eye Drops EMDN Q02030301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04260595530986 Basic UDI-DIDate27 May 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  • Withdrawn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 24 Oct 2026

Device Name
Sodium Hyaluronate 0.3% Eye Drops
Model / Reference
Moisturizing Eye Drops, 41019300L
Primary DI / UDI-DI
04260595530986
Basic UDI-DI
B-04260595530986
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006565

Other devices from Penta Arzneimittel GmbH

See all devices from Penta Arzneimittel GmbH →

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 5c909189-3545-434e-83be-0efbadd5de55 61 fields · synced 24 Oct 2026