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BIOSYNEX Bladder Tumor Antigen

by Biosynex France EUDAMED

Ref 1110004 EMDN W0102030101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03700531700642 Basic UDI-DIDate12 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  • Withdrawn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 25 Oct 2026

Model / Reference
1110004
Primary DI / UDI-DI
03700531700642
Basic UDI-DI
B-03700531700642
EMDN Code
W0102030101 Bladder tumour antigen
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f59ad87c-154b-4ea6-a12f-ebbf40767477 61 fields · synced 25 Oct 2026