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Universal Sequencing Reaction Kit T1+ FCL SE100

by Shenzhen MGI Biological Electronic Technology Co., Ltd. EUDAMED

Active European Union

Ref 940-002764-00

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697599627S-Kit35 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Universal Sequencing Reaction Kit
Model / Reference
940-002764-00
Primary DI / UDI-DI
06975996270369
Basic UDI-DI
697599627S-Kit35
Direct Marketing DI
06975996270369
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000044825
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No