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PathVysion

by Abbott Molecular Inc. 3 variants

Ref 06N46-035

PathVysion (06N46-035) is a device classified as IVD General made by Abbott Molecular, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00884999035874), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00884999035874 Basic UDI-DI 00884999035874UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
PathVysion HER-2 DNA Probe Kit
Model / reference
06N46-035
Primary DI / UDI-DI
00884999035874
Basic UDI-DI
B-00884999035874
EMDN code
W01060213, W01060214
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
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
  • Companion diagnostics
Other properties (7, all answered No)