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UriFind® Bladder Cancer Assay Kit

by AnchorDx Medical Co.Ltd. China EUDAMED

Ref 40 Tests EMDN W01060215

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975240820159 Basic UDI-DIDate22 May 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  • Withdrawn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 24 Oct 2026

Device Name
UriFind® Bladder Cancer Assay Kit
Model / Reference
40 Tests
Primary DI / UDI-DI
06975240820159
Basic UDI-DI
B-06975240820159
EMDN Code
W01060215 Bladder cancer detection / monitoring
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000054821
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from AnchorDx Medical Co.Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e96660a2-e48c-4a58-973d-9a9c8db94923 61 fields · synced 24 Oct 2026