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GeneMind

by GeneMind Biosciences Co., Ltd. 61 variants

Ref S000335Model 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

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 Number697496858BR01SURF50005C Basic UDI-DI 06974968583711UDI-DIDate7 Jun 2024RegisteredStatusActive

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  • Withdrawn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
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, S000335
Primary DI / UDI-DI
06974968583711
Basic UDI-DI
697496858BR01SURF50005C
Direct Marketing DI
06974968583711
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

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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