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Automated Microbial Detection System

by Autobio Labtec Instruments Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref 05132Model AutoBes X, AutoBes X-R

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  • Withdrawn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European Union — CE/IVDR Withdrawn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

Device Name
Automated Microbial Detection System
Model / Reference
AutoBes X, AutoBes X-R, 05132
Primary DI / UDI-DI
06973049097444
Basic UDI-DI
697304909Model023FR
Direct Marketing DI
06973049097444
EMDN Code
W02030201 Automated blood culture analysers
Device Class
Class A

Manufacturer details

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

Other devices from Autobio Labtec Instruments Co., Ltd.

See all devices from Autobio Labtec Instruments Co., Ltd. →

Properties

Show properties
  • Surgical Instrument
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No