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PENTAX Medical Video Colonoscope EC34-i10cM

by PENTAX Medical Corporation Japan EUDAMED

Ref 04580826920455Model See UDI-DI information for model names

EMDN Z12020606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number458082692010102KH Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PENTAX Medical Video Colonoscope
Model / Reference
See UDI-DI information for model names, 04580826920455
Primary DI / UDI-DI
04580826920455
Basic UDI-DI
458082692010102KH
Direct Marketing DI
04580826922978
EMDN Code
Z12020606 Video colonoscopes
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000005227
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from PENTAX Medical Corporation

See all devices from PENTAX Medical Corporation →

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 682433c2-f9a7-4748-8617-0b21d8dabee4 61 fields · synced 24 Oct 2026