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Ea Sol Balanced Salt Solution

by Serumwerk Bernburg AG Germany EUDAMED

Ref 1251Model Balanced salt solution EMDN Q02030203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426020097BSSC5 Basic UDI-DIDate9 Apr 2024RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 23 Oct 2026

Device Name
Eye-Lotion Balanced salt solution
Model / Reference
Balanced salt solution, 1251
Primary DI / UDI-DI
04260200971562
Basic UDI-DI
426020097BSSC5
Direct Marketing DI
04260200971562
EMDN Code
Q02030203 Ophthalmic surgery balanced saline solutions
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
DE-MF-000005169

Other devices from Serumwerk Bernburg AG

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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 dd41ea3d-2293-4af3-8d4e-ae7248114426 61 fields · synced 23 Oct 2026