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Virtual Geneticist® (VG) AI genomics analysis platform

by Breakthrough Genomics Inc. EUDAMED

Active European Union

Ref VG888

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600162321VG888GB Basic UDI-DIDate28 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Virtual Geneticist® (VG) AI genomics analysis platform
Model / Reference
VG888
Primary DI / UDI-DI
00884400876683
Basic UDI-DI
08600162321VG888GB
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000058327
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Properties

  • Professional Testing

Other properties (10)

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