Skip to content

Sample Processing System

by Changsha Imadek Intelligent Technology Co., Ltd. China EUDAMED

Ref Magic-8400Model Magic-4000,Magic-8000,Magic-8000Plus,Magic-9000,Magic-8200,Magic-8200Plus,Magic-8400,Magic-8400Plus

EMDN W02069099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697431271003H6 Basic UDI-DIDate21 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

Model / Reference
Magic-4000, Magic-8000, Magic-8000Plus, Magic-9000, Magic-8200, Magic-8200Plus, Magic-8400, Magic-8400Plus
Primary DI / UDI-DI
06974312710497
Basic UDI-DI
697431271003H6
Direct Marketing DI
06974312710497
EMDN Code
W02069099 Various sample processing instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000042852
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Changsha Imadek Intelligent Technology Co., Ltd.

See all devices from Changsha Imadek Intelligent Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 8c3581b8-4448-4738-8a22-3b4bd0e0e400 61 fields · synced 24 Oct 2026