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Flex-disc

by Shenzhen Chenghui Medical Technology Co., Ltd. China EUDAMED

Ref CH-0104

EMDN W02010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697552996CH-0104GM Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Fully Automated Nucleic Acid Analyzer
Model / Reference
CH-0104
Primary DI / UDI-DI
06975529960040
Basic UDI-DI
697552996CH-0104GM
Direct Marketing DI
06975529960040
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000046638
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Shenzhen Chenghui Medical Technology Co., Ltd.

See all devices from Shenzhen Chenghui Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • New Device
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 28b31b19-32e2-457b-a1b3-9bdd713c5730 61 fields · synced 24 Oct 2026