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Genetic Sequencer HELICON® G400

by Wuhan MGI Tech Co., Ltd.

Ref 900-000742-00Model DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G50

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697431813SEQSY Basic UDI-DI 06974318131906UDI-DIDate9 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Genetic Sequencer
Model / Reference
DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G50, 900-000742-00
Primary DI / UDI-DI
06974318131906
Basic UDI-DI
697431813SEQSY
Direct Marketing DI
06974318131906
EMDN Code
W02050108 Genetic system readers
Device Class
Class A
EU 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