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Automated Nucleic Acid Extractor MGISP-NE384

by Wuhan MGI Tech Co., Ltd. EUDAMED

Active European Union

Ref 900-000359-00Model MGISP-NE32, MGISP-NE384, MGISP-NEX

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697431813MGISP-NEB4 Basic UDI-DIDate24 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Device Name
Automated Nucleic Acid Extractor
Model / Reference
MGISP-NE32, MGISP-NE384, MGISP-NEX, 900-000359-00
Primary DI / UDI-DI
06974318130466
Basic UDI-DI
697431813MGISP-NEB4
Direct Marketing DI
06974318130466
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Market of Registration
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000018732
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Wuhan MGI Tech Co., Ltd.

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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