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Versa

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

Ref EN18-V10cTModel EN11-V10c, EN15-V10c, EN15-V10cT, EN18-V10cT

EMDN Z12021004

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697227211ENY3 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 Laryngoscope
Model / Reference
EN11-V10c, EN15-V10c, EN15-V10cT, EN18-V10cT
Primary DI / UDI-DI
06972272110173
Basic UDI-DI
697227211ENY3
Direct Marketing DI
06972272110173
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 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 aaae942a-3459-4997-a554-c43760b4af29 61 fields · synced 22 Oct 2026