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Versa

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

Ref EC38-V12cMModel EC38-V10cM, EC38-V10cL, EC38-V12cM, EC38-V12cL

EMDN Z12020606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697227211ECXD Basic UDI-DIDate19 May 2026RegisteredStatusActive

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
EC38-V10cM, EC38-V10cL, EC38-V12cM, EC38-V12cL
Primary DI / UDI-DI
06972272110227
Basic UDI-DI
697227211ECXD
Direct Marketing DI
06972272110227
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 IIa

  • Versa

    Class IIa

  • Versa

    Class I

  • Versa

    Class IIa

See all devices from PENTAX-Aohua Medical Technologies Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 85c1cf29-fe81-45c1-b860-7e4b964af2db 61 fields · synced 22 Oct 2026