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Versa

by PENTAX-Aohua Medical Technologies Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref EC38-V12cLModel EC38-V10cM, EC38-V10cL, EC38-V12cM, EC38-V12cL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697227211ECXD Basic UDI-DIDate19 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
PENTAX Medical Video Colonoscope
Model / Reference
EC38-V10cM, EC38-V10cL, EC38-V12cM, EC38-V12cL
Primary DI / UDI-DI
06972272110234
Basic UDI-DI
697227211ECXD
Direct Marketing DI
06972272110234
EMDN Code
Z12020606 Video colonoscopes
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000005686
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from PENTAX-Aohua Medical Technologies Co., Ltd.

  • Versa

    Class IIa

  • Versa

    Class IIa

  • Versa

    Class I

  • Versa

    Class IIa

  • Versa

    Class IIa

  • Versa

    Class IIa

Properties

  • CMR Substance

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No