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RARA (17q21) probe reagent

by Wuhan HealthCare Biotechnology Co., Ltd. China EUDAMED

Ref FP-005 EMDN W01060299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697180825KFP005H4UW Basic UDI-DIDate5 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
RARA (17q21) probe reagent
Model / Reference
FP-005
Primary DI / UDI-DI
D-697180825KFP005H4UW
Basic UDI-DI
B-697180825KFP005H4UW
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-697180825KFP005H4UW|B-697180825KFP005H4UW 61 fields · synced 25 Oct 2026