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Sentol

by Serumwerk Bernburg AG Germany EUDAMED

Ref 1249Model Balanced salt solution

EMDN Q02030203

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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, 1249
Primary DI / UDI-DI
04260200970794
Basic UDI-DI
426020097BSSC5
Direct Marketing DI
04260200970794
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

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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 179a2661-55ae-44d9-89e2-8d1ba4234364 61 fields · synced 22 Oct 2026