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ocular®

by Penta Arzneimittel GmbH Germany EUDAMED

Ref 41067400LModel Hypertonic Eye Drops

EMDN Q02030299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04260595531679 Basic UDI-DIDate27 May 2026RegisteredStatusActive

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

Device Name
Sodium Chloride 5% Eye Drops
Model / Reference
Hypertonic Eye Drops, 41067400L
Primary DI / UDI-DI
04260595531679
Basic UDI-DI
B-04260595531679
EMDN Code
Q02030299 Ophthalmology, liquid fluids - other
Device Class
Class IIb
Market of Registration
Portugal

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 4fabdf77-ecaf-4f0d-8278-7ebc02f16090 61 fields · synced 22 Oct 2026