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DEK / NUP214 t(6;9) Fusion

by Kreatech Biotechnology B.V.

Ref KBI-10306

Active European Union

CE IVDD

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/IVDD NumberB-08717973347989 Basic UDI-DI 08717973347989UDI-DIDate22 Sep 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Kreatech™ DEK / NUP214 t(6;9) Fusion FISH probe
Model / Reference
KBI-10306
Primary DI / UDI-DI
08717973347989
Basic UDI-DI
B-08717973347989
EMDN Code
W01030703 DNA in situ hybridisation reagents
Models / Variants
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000006048

Other devices from Kreatech Biotechnology B.V.

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No