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Non-small cell lung cancer mutation analysis software

by Bgi Europe a/S EUDAMED

Active European Union

Ref /Model Osmart-T-lung-1 Osmart-T-lung-2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05744003510085 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Non-small cell lung cancer mutation analysis software
Model / Reference
Osmart-T-lung-1 Osmart-T-lung-2, /
Primary DI / UDI-DI
05744003510085
Basic UDI-DI
B-05744003510085
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

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Properties

Show properties
  • 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