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OncoFFPE-GeneSGKit Mamma 12 reacciones

by Sistemas Genomicos. S.L.

Ref LV4440Model OncoFFPE-GeneSGKit Mamma 12 reacciones

Active European Union

CE IVDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436566762779 Basic UDI-DI 08436566762779UDI-DIDate13 Jan 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
OncoFFPE-GeneSGKit Mamma 12 reacciones, LV4440
Primary DI / UDI-DI
08436566762779
Basic UDI-DI
B-08436566762779
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000022949

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Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No