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GeneMind

by GeneMind Biosciences Co., Ltd. 61 variants

Ref S000400Model FCM 150cycles,FCM 300cycles,FCH-D SE075-D,FCH 300cycles,FCH 150cycles,FCM-D SE075-D,GenoLab FCM 150cycles,GenoLab FCM 300cycles,GenoLab FCM-D SE075-D,GenoLab FCH 150cycles,GenoLab FCH 300cycles,GenoLab FCH-D SE075-D

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697496858R-Kit2U Basic UDI-DI 06974968583476UDI-DIDate16 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Universal Reaction Kit for Sequencing（Reversible Terminator Sequencing）
Model / Reference
FCM 150cycles, FCM 300cycles, FCH-D SE075-D, FCH 300cycles, FCH 150cycles, FCM-D SE075-D, GenoLab FCM 150cycles, GenoLab FCM 300cycles, GenoLab FCM-D SE075-D, GenoLab FCH 150cycles, GenoLab FCH 300cycles, GenoLab FCH-D SE075-D, S000400
Primary DI / UDI-DI
06974968583476
Basic UDI-DI
697496858R-Kit2U
Direct Marketing DI
06974968583476
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
EU 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

  • 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