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Omnisol

by Vivalyx GmbH EUDAMED

Active European Union

Ref OMN-1000

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426255283OMNISOLKIDCOLD5N Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 809923 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    18 Aug 2026
    Expires
    17 Aug 2031

Specification

EUDAMED

Device Name
Omnisol
Model / Reference
OMN-1000
Primary DI / UDI-DI
04262552830009
Basic UDI-DI
426255283OMNISOLKIDCOLD5N
EMDN Code
A090102 Organ preservation solutions
Device Class
Class III
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
DE-MF-000045202

Properties

  • 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