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

Ref EG27-V10cModel EG27-V10c, EG29-V10c, EG29-V12c

EMDN Z12020511

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06972272110012 Basic UDI-DIDate21 May 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06972272110012 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PENTAX Medical Video Gastroscope
Model / Reference
EG27-V10c, EG29-V10c, EG29-V12c
Primary DI / UDI-DI
06972272110012
Basic UDI-DI
B-06972272110012, 697227211EGXM
Direct Marketing DI
06972272110012
EMDN Code
Z12020511 Video gastroscopes
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

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

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

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 (2)

  • EUDAMED 1be43af8-bd34-4d74-a13a-307f19603f95 61 fields · synced 22 Oct 2026
  • EUDAMED a17eb9d3-5bd5-4241-96b6-7ee950d5b288 61 fields · synced 6 Oct 2026