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ColoMaia II

by MAIA LABS s.r.o. EUDAMED

Active European Union

Ref 08594225430015Model ColoMaia II

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859422543ColoMaiaIINK Basic UDI-DIDate26 May 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  • Withdrawn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)
  • 2026-MDR/QS-027 Issued

    Quality management system EU MDR

    Notified body
    3EC International a.s. 2265
    Issued
    25 May 2026
    Expires
    25 May 2031

Specification

EUDAMED

Model / Reference
ColoMaia II, 08594225430015
Primary DI / UDI-DI
08594225430015
Basic UDI-DI
859422543ColoMaiaIINK
Direct Marketing DI
08594225430015
EMDN Code
G030701 Gastrointestinal imaging diagnostic devices
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000044767

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