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Vysis

by Abbott Molecular Inc. 32 variants

Ref 05N46-020

Vysis (05N46-020) is a Class C device made by Abbott Molecular, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 0884999VyN0546SG), 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 Number0884999VyN0546SG Basic UDI-DI 00884999014954UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Vysis RARA Break Apart FISH Probe Kit
Model / reference
05N46-020
Primary DI / UDI-DI
00884999014954
Basic UDI-DI
0884999VyN0546SG
EMDN code
W01060299 Tests for acquired genetic or chromosomal alterations - other
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

Similar devices in this category

Other devices filed under TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER.

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

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