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Fast Fluorescence In Situ Hybridization Probe Kit

by Wuhan HealthCare Biotechnology Co., Ltd.

Ref FP-006

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06971808256774W7 Basic UDI-DI Date6 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06971808256774W7 Basic UDI-DI Date6 Jul 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  • Withdrawn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/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
6q probe reagent
Model / Reference
FP-006
Primary DI / UDI-DI
D-06971808256774W7, 06971808256774
Basic UDI-DI
B-06971808256774W7, 697180825KFP006H6
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
Class C
EU market of registration
Czechia

Manufacturer details

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

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Properties

  • Microbial Substances NoEUDAMEDYesEUDAMED
  • 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