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Eye-Lotion Balanced salt solution

by Serumwerk Bernburg Vertriebs GmbH Germany EUDAMED

Ref 1395

EMDN Q02030203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-DEMF00000500213954Q Basic UDI-DIDate6 Apr 2023RegisteredStatusActive

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
Eye-Lotion Balanced salt solution, 500 ml PP-bottle
Model / Reference
1395
Primary DI / UDI-DI
D-DEMF00000500213954Q
Basic UDI-DI
B-DEMF00000500213954Q
EMDN Code
Q02030203 Ophthalmic surgery balanced saline solutions
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005002

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See all devices from Serumwerk Bernburg Vertriebs GmbH →

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 be28bcd4-8493-41c1-947d-0d25b24cd073 61 fields · synced 22 Oct 2026