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UroVysion

by Abbott Molecular Inc. 3 variants

Ref 02J27-020

UroVysion (02J27-020) is a Class C device made by Abbott Molecular, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0884999VyJ0227QH), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0884999VyJ0227QH Basic UDI-DI 00884999002135UDI-DIDate28 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
UroVysion Bladder Cancer Kit
Model / reference
02J27-020
Primary DI / UDI-DI
00884999002135
Basic UDI-DI
0884999VyJ0227QH
EMDN code
W01060215 Bladder cancer detection / monitoring
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000017776
Authorised representative
Abbott GmbH DE-AR-000009457

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Properties

  • Contains human tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)