Skip to content

Versa

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

Withdrawn Not intended for the EU market

Ref EN15-V10cModel EN11-V10c, EN15-V10c, EN15-V10cT, EN18-V10cT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697227211ENY3 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  • Withdrawn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European Union — CE/MDR Withdrawn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 Laryngoscope
Model / Reference
EN11-V10c, EN15-V10c, EN15-V10cT, EN18-V10cT
Primary DI / UDI-DI
06972272110159
Basic UDI-DI
697227211ENY3
Direct Marketing DI
06972272110159
EMDN Code
Z12021004 Video laryngoscopes
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