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GeneMind

by GeneMind Biosciences Co., Ltd. China EUDAMED

Ref SQ00078Model FASTASeq S Dx

EMDN W02050108

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697496858AH01FASTASeqSYL Basic UDI-DIDate8 Jan 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

Device Name
FASTASeq S Dx Sequencing System
Model / Reference
FASTASeq S Dx, SQ00078
Primary DI / UDI-DI
06974968581090
Basic UDI-DI
697496858AH01FASTASeqSYL
EMDN Code
W02050108 Genetic system readers
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000025785
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from GeneMind Biosciences Co., Ltd.

See all devices from GeneMind Biosciences 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 0fead89e-801a-490e-9b3f-ae95c4f746a1 61 fields · synced 24 Oct 2026