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BacterioChek® - TB Software

by Advanced Biological Laboratories (Abl) S.A. Luxembourg EUDAMED

Ref S-12-023 (TM) EMDN W02050192

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05407007960224 Basic UDI-DIDate15 Sep 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
S-12-023 (TM)
Primary DI / UDI-DI
05407007960224
Basic UDI-DI
B-05407007960224
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
Luxembourg

Manufacturer details

EUDAMED SRN
LU-MF-000003752

Other devices from Advanced Biological Laboratories (Abl) S.A.

See all devices from Advanced Biological Laboratories (Abl) S.A. →

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 05407007960224|B-05407007960224 61 fields · synced 25 Oct 2026