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AutoMic-i600

by Autobio Labtec Instruments Co., Ltd. China EUDAMED

Ref 05021Model AutoMic-i600

EMDN W0104080101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model61UJ Basic UDI-DIDate6 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Automated Microorganism Identification and Antimicrobial Susceptibility Testing Analyzer
Model / Reference
AutoMic-i600, 05021
Primary DI / UDI-DI
06973049096119
Basic UDI-DI
697304909Model61UJ
Direct Marketing DI
06973049096119
EMDN Code
W0104080101 Gram negative identification - automated
Device Class
Class A
Market of Registration
Türkiye

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 & 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 32679063-3cf3-4532-b7d5-4860e7794675 61 fields · synced 22 Oct 2026