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Onco-GeneSGKit Mamma 12 reacciones

by Sistemas Genomicos S.L.

Ref LV2537Model Onco-GeneSGKit Mamma

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-08436566760560 Basic UDI-DI 08436566760560UDI-DIDate27 May 2022RegisteredStatusActive

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  • Withdrawn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
Onco-GeneSGKit Mamma
Model / Reference
Onco-GeneSGKit Mamma, LV2537
Primary DI / UDI-DI
08436566760560
Basic UDI-DI
B-08436566760560
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000022949

Other devices from Sistemas Genomicos. S.L.

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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