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GeneMind

by GeneMind Biosciences Co., Ltd. 61 variants

Ref S000399Model FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-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 Number697496858FASTASeq-Kit2W Basic UDI-DI 06974968583636UDI-DIDate14 Jul 2023RegisteredStatusActive

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  • Withdrawn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
FASTA FCM 150, FASTA FCM 300, FASTA FCM-D 75-D, FASTA FCH 150, FASTA FCH 300, FASTA FCH-D 75-D, S000399
Primary DI / UDI-DI
06974968583636
Basic UDI-DI
697496858FASTASeq-Kit2W
Direct Marketing DI
06974968583636
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