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ColonPRO™ EU

by Linkverse S.R.L. Italy EUDAMED

Ref CPRO41S-EU

EMDN Z12020692

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberEPT 0477.MDR.23/5274.1 Date31 Oct 2025IssuedStatusActive expires 30 Oct 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.23/5274.1 Reissued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    31 Oct 2025
    Expires
    30 Oct 2028

Specification

EUDAMED · synced 24 Oct 2026

Device Name
GI Genius™ software
Model / Reference
CPRO41S-EU
Primary DI / UDI-DI
08055060110352
Basic UDI-DI
805506011SWDCBB
EMDN Code
Z12020692 Lower gastrointestinal tract endoscopy instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029440

Other devices from Linkverse S.R.L.

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 45999502-b99f-4357-bdca-00fb75a553a6 61 fields · synced 24 Oct 2026