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Fast Fluorescence In Situ Hybridization Probe Kit

by Wuhan HealthCare Biotechnology Co., Ltd. China EUDAMED

Ref FP-004 EMDN W01060299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697180825KFP004H2 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
AML1/ETO gene fusion detection kit
Model / Reference
FP-004
Primary DI / UDI-DI
06971808256392
Basic UDI-DI
697180825KFP004H2
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
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.

See all devices from Wuhan HealthCare Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • 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

Sources (1)

  • EUDAMED 06971808256392|697180825KFP004H2 61 fields · synced 25 Oct 2026