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AutoBC 450s

by Autobio Labtec Instruments Co., Ltd. China EUDAMED

Ref 05132Model AutoBC 450 AutoBC 450 AutoBC 450 Series-SL

EMDN W02030201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model032FS Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Automated Microbial Detection System
Model / Reference
AutoBC 450 AutoBC 450 AutoBC 450 Series-SL, 05132
Primary DI / UDI-DI
06973049094467
Basic UDI-DI
697304909Model032FS
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

Other devices from Autobio Labtec Instruments Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • 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

Sources (1)

  • EUDAMED 06973049094467|697304909MODEL032FS 61 fields · synced 24 Oct 2026