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Lower Gastrointestinal Video Endoscope

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

Ref EC-200LModel EC-200

EMDN Z12020606

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69454290VE002PN Basic UDI-DIDate22 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
EC-200, EC-200L
Primary DI / UDI-DI
06945429028645
Basic UDI-DI
69454290VE002PN
Direct Marketing DI
06945429028645
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 32225725-441f-4e1c-bb73-2363ac8b08ab 61 fields · synced 22 Oct 2026