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Automated Mass Spectrometry Microbial Identification System

by Autobio Labtec Instruments Co., Ltd. China EUDAMED

Ref 11092Model Autof TX8 EMDN W020303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model720GN Basic UDI-DIDate14 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Automated Mass Spectrometry Microbial Identification System
Model / Reference
Autof TX8, 11092
Primary DI / UDI-DI
06973049099073
Basic UDI-DI
697304909Model720GN
EMDN Code
W020303 Mass - spectrometry system
Device Class
Class C
Market of Registration
France

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED c3067a53-b037-4816-bcc6-5d442756d83a 61 fields · synced 22 Oct 2026