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Pure-Vu EU EVS Colon Kit, 5-Pack

by Motus GI Medical Technologies Ltd EUDAMED

Active European Union

Ref PV-COL-04-1EModel Gen 4

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506051370GEN42U Basic UDI-DIDate26 Apr 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  • Withdrawn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)
  • 3902947CE01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    21 Oct 2024
    Expires
    1 Oct 2029

Specification

EUDAMED

Device Name
Pure Vu EU EVS System
Model / Reference
Gen 4, PV-COL-04-1E
Primary DI / UDI-DI
05060513700458
Basic UDI-DI
506051370GEN42U
EMDN Code
Z12020685 Lower gastrointestinal tract endoscopy instruments - consumables
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000032622
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show properties
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