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Uromonitor

by Infogene, Lda. Portugal EUDAMED

Ref UROM01

EMDN W01060215

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-infogene_CP Basic UDI-DIDate23 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
UROM01
Primary DI / UDI-DI
D-infogene_CP
Basic UDI-DI
B-infogene_CP
EMDN Code
W01060215 Bladder cancer detection / monitoring
Device Class
Class IVD General
Market of Registration
Portugal

Manufacturer details

EUDAMED SRN
PT-MF-000047847

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 9a8346b0-5ff3-4ad0-835e-d935e863d49c 61 fields · synced 22 Oct 2026