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GeneMind

by GeneMind Biosciences Co., Ltd. China EUDAMED

Ref S000497Model S-1 FCL-D 100-D,S-1 FCL 100,S-1 FCL 300,S-1 FCM-D 100-D,S-1 FCM 100,S-1 FCM 300

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697496858BZ01UU 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 22 Oct 2026

Device Name
FASTASeq S Dx Universal Reaction Kit for Sequencing
Model / Reference
S-1 FCL-D 100-D, S-1 FCL 100, S-1 FCL 300, S-1 FCM-D 100-D, S-1 FCM 100, S-1 FCM 300, S000497
Primary DI / UDI-DI
06974968583872
Basic UDI-DI
697496858BZ01UU
Direct Marketing DI
06974968583872
EMDN Code
W010699 Genetic tests - other
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
  • 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

Sources (1)

  • EUDAMED 9efe7860-d8a2-4b5c-aacd-9a7b15c4d495 61 fields · synced 22 Oct 2026