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Lower Gastrointestinal Video Endoscope

by Shenzhen Comen Medical Instruments Co., LTD. China EUDAMED

Ref EC-300SPLModel EC-300XPL EMDN Z12020606

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69454290VE009Q4 Basic UDI-DIDate12 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
EC-300XPL, EC-300SPL
Primary DI / UDI-DI
06945429062847
Basic UDI-DI
69454290VE009Q4
Direct Marketing DI
06945429062847
EMDN Code
Z12020606 Video colonoscopes
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000002236
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Comen Medical Instruments Co., Ltd.

See all devices from Shenzhen Comen Medical Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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 194ae67f-5aba-4b87-90e8-10f16272e424 61 fields · synced 22 Oct 2026