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FHD Integrated Imaging System for Endoscope

by GUANGXI VISUALTECH S&T Co., LTD. China EUDAMED

Ref ZHDY-22001AModel ZHDY-26001A,ZHDY-22001A EMDN Z12020703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698008798003MD Basic UDI-DIDate21 May 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  • Withdrawn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 24 Oct 2026

Model / Reference
ZHDY-26001A,ZHDY-22001A, ZHDY-22001A
Primary DI / UDI-DI
06980087980058
Basic UDI-DI
698008798003MD
Direct Marketing DI
06980087980058
EMDN Code
Z12020703 Colposcopes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000054392
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from GUANGXI VISUALTECH S&T Co., LTD.

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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 6ea4a097-73cb-4ad6-8307-1ca5870c33aa 61 fields · synced 24 Oct 2026