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Solid Tumor Multi-Gene Combined Detection Analysis Software

by Bgi Europe a/S Denmark EUDAMED

Ref MFG020007Model Sentis-PanCancer, Sentis-PanCancer-CL

EMDN W01060202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05745000468508 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Solid Tumor Multi-Gene Combined Detection Analysis Software
Model / Reference
Sentis-PanCancer, Sentis-PanCancer-CL, MFG020007
Primary DI / UDI-DI
05745000468508
Basic UDI-DI
B-05745000468508
EMDN Code
W01060202 K-ras
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • 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

Sources (1)

  • EUDAMED 91ce1ed3-8970-427b-ba97-b49e2decae12 61 fields · synced 23 Oct 2026