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PENTAX Medical Video Colonoscope EC38-i10cF

by HOYA Corporation Japan EUDAMED

Ref 6217001S216SModel See UDI-DI information for model names

EMDN Z12020606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4961333010102XE Basic UDI-DIDate10 Jan 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PENTAX Medical Video Colonoscope
Model / Reference
See UDI-DI information for model names, 6217001S216S
Primary DI / UDI-DI
04961333237968
Basic UDI-DI
4961333010102XE
Direct Marketing DI
04961333237937
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 HOYA Corporation

See all devices from HOYA Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 3a9ffc36-e5ad-415e-867f-bc2a78366d50 61 fields · synced 22 Oct 2026