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Automated Microbial Detection System

by Autobio Labtec Instruments Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref 05131Model AutoBes X, AutoBes X-R, AutoBC 450 AutoBC 450 AutoBC 450 Series-SL

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model023FR Basic UDI-DIDate12 Jun 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AutoBes X, AutoBes X-R, 05131, AutoBC 450 AutoBC 450 AutoBC 450 Series-SL
Primary DI / UDI-DI
06973049097437, 06973049094474
Basic UDI-DI
697304909Model023FR, 697304909Model032FS
Direct Marketing DI
06973049097437
EMDN Code
W02030201 Automated blood culture analysers
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000012110
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show properties
  • Professional Testing NoEUDAMEDYesEUDAMED
  • Surgical Instrument
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
  • New Device: No