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GENEYE® System

by Suzhou GenDx Biotech Co., Ltd. EUDAMED

Active European Union

Ref GCP-30Model GCP-30/GE4/GD-220

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697510228GD0017D Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
GENEYE® System
Model / Reference
GCP-30/GE4/GD-220, GCP-30
Primary DI / UDI-DI
06975102280169
Basic UDI-DI
697510228GD0017D
Direct Marketing DI
06975102280169
EMDN Code
W02050199,W02050201,W02050301
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000018830
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Suzhou GenDx Biotech Co., Ltd.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No