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GeneMind

by GeneMind Biosciences Co., Ltd. China EUDAMED

Ref S000583Model SFCMS-1 FCM 100

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697496858BR01-CMS6M Basic UDI-DIDate17 Aug 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
SURFSeq 5000 Dx CMS Universal Reaction Kit for Sequencing
Model / Reference
SFCMS-1 FCM 100, S000583
Primary DI / UDI-DI
06974968584367
Basic UDI-DI
697496858BR01-CMS6M
Direct Marketing DI
06974968584367
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 5c14aed7-e8a8-4924-8a20-1d858237eb6e 61 fields · synced 24 Oct 2026