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BIOLAN® gel

by Penta Arzneimittel GmbH EUDAMED

Withdrawn Not intended for the EU market

Ref 41074600Model Moisturizing Eye Drops

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426059553MP23UD01K8 Basic UDI-DIDate29 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sodium Hyaluronate 0.3% Eye Drops
Model / Reference
Moisturizing Eye Drops, 41074600
Primary DI / UDI-DI
14260595530112
Basic UDI-DI
426059553MP23UD01K8
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
DE-MF-000006565

Other devices from Penta Arzneimittel GmbH

See all devices from Penta Arzneimittel GmbH →

Properties

Show properties
  • 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