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Fast Fluorescence In Situ Hybridization Probe Kit

by Wuhan HealthCare Biotechnology Co., Ltd. 101 variants

Ref FP-002

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number697180825KFP002GW Basic UDI-DI Date19 May 2026RegisteredStatusActive
European UnionCE/IVDR Number697180825KFP002GW Basic UDI-DI Date19 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
Human ALK gene fusion detection probe
Model / Reference
FP-002
Primary DI / UDI-DI
06971808256378, D-06971808256378VT
Basic UDI-DI
697180825KFP002GW, B-06971808256378VT
EMDN Code
W01060299, W01060213
Device Class
Class C
Class IVD General
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000033113
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Wuhan HealthCare Biotechnology Co., Ltd.

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Properties

  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (8)

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