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Bss Distra-Sol

by Serumwerk Bernburg AG Germany EUDAMED

Ref 1222, 1221Model Balanced salt solution EMDN Q02030203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426020097BSSC5 Basic UDI-DIDate9 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Eye-Lotion Balanced salt solution
Model / Reference
Balanced salt solution, 1222, 1221
Primary DI / UDI-DI
04260200970923, 04260200970916
Basic UDI-DI
426020097BSSC5
Direct Marketing DI
04260200970923
04260200970916
EMDN Code
Q02030203 Ophthalmic surgery balanced saline solutions
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005169

Other devices from Serumwerk Bernburg AG

See all devices from Serumwerk Bernburg AG →

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 (2)

  • EUDAMED f12289c6-889c-4223-b185-d2cc5ee1a378 61 fields · synced 22 Oct 2026
  • EUDAMED 04260200970916|426020097BSSC5 61 fields · synced 18 May 2026