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GeneMind

by GeneMind Biosciences Co., Ltd. EUDAMED

Active European Union

Ref S000339Model FCM 100/200/300 cycles,FCH 50/100/200/300 cycles,SURF FCM 100/200/300 cycles,SURF FCH 50/100/200/300 cycles,SURF FCP 50/100/200/300 cycles

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697496858BR01SURF50005C Basic UDI-DIDate7 Jun 2024RegisteredStatusActive

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  • Withdrawn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
SURFSeq 5000 Dx Universial Reaction Kit for Sequencing
Model / Reference
FCM 100/200/300 cycles, FCH 50/100/200/300 cycles, SURF FCM 100/200/300 cycles, SURF FCH 50/100/200/300 cycles, SURF FCP 50/100/200/300 cycles, S000339
Primary DI / UDI-DI
06974968583759
Basic UDI-DI
697496858BR01SURF50005C
Direct Marketing DI
06974968583759
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

Show properties
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No