Skip to content

Automatic nucleic acid extractor

by Changsha Imadek Intelligent Technology Co., Ltd. EUDAMED

Active European Union

Ref SMART-4596PlusModel SMART-0596,SMART-4000,SMART-8000,SMART-4596Plus,SMART-4596Pro, SMART-8000Plus,SMART-4000Plus,Victoria_V96,Ava_V48,SMART-0548Mini

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697431271001H2 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
SMART-0596, SMART-4000, SMART-8000, SMART-4596Plus, SMART-4596Pro, SMART-8000Plus, SMART-4000Plus, Victoria_V96, Ava_V48, SMART-0548Mini
Primary DI / UDI-DI
06974312710619
Basic UDI-DI
697431271001H2
Direct Marketing DI
06974312710619
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

  • 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