Skip to content

Glimessen

by Hangzhou Hikimaging Electronics Co., Ltd. China EUDAMED

Ref S545XModel GET-S545XSI1

EMDN Z12020406

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697790480GS545XSI10000CW Basic UDI-DIDate19 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Endoscope Image Processor
Model / Reference
GET-S545XSI1, S545X
Primary DI / UDI-DI
06977904802105
Basic UDI-DI
697790480GS545XSI10000CW
EMDN Code
Z12020406 Video processors
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000046099
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Hikimaging Electronics Co., Ltd.

See all devices from Hangzhou Hikimaging Electronics 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 50d47e1f-7766-44bb-a999-c48f83033f29 61 fields · synced 24 Oct 2026