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Flow Cell

by Geneus Technologies (Chengdu) Co., Ltd. China EUDAMED

Ref G-MK02 5 Flow Cells / KitModel G-MK02

EMDN W02050385

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697911702GS002ES Basic UDI-DIDate19 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Flow Cell
Model / Reference
G-MK02, G-MK02 5 Flow Cells / Kit
Primary DI / UDI-DI
06979117020031
Basic UDI-DI
697911702GS002ES
EMDN Code
W02050385 Nucleic acid testing instruments - rapid and point of care tests - consumables
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000050313
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Geneus Technologies (Chengdu) Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED c927c9f4-895c-4494-8c86-35b8618fcaf0 61 fields · synced 22 Oct 2026