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Microbial Detection System

by Autobio Labtec Instruments Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref 05123, 05121, 05111，05112，05115，05116，05117，05118，05119Model BC120 Plus, BC120 Plus-240, BC120 Plus-600, BC60， BC60 Se，BC60-120， BC60-180，BC60-240，BC60-300，BC60-360

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model020FK 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  • Withdrawn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European Union — CE/IVDR Withdrawn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
BC120 Plus, BC120 Plus-240, BC120 Plus-600, 05123, 05121, BC60， BC60 Se，BC60-120， BC60-180，BC60-240，BC60-300，BC60-360, 05111，05112，05115，05116，05117，05118，05119
Primary DI / UDI-DI
06973049097420, 06973049097406, 06973049096218
Direct Marketing DI
06973049097420
06973049097406
Market of Registration
Italy

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 NoEUDAMEDYesEUDAMED
  • Surgical Instrument
  • New Device NoEUDAMEDYesEUDAMED
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 (3)

  • EUDAMED 46258d12-6fe4-4a84-88a7-37abb3a71112 61 fields · synced 24 Oct 2026
  • EUDAMED 06973049097406|697304909MODEL020FK 61 fields · synced 17 May 2026
  • EUDAMED 06973049096218|697304909MODEL62UL 61 fields · synced 18 May 2026