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Automated Blood Culture System

by Biobase Biodustry(Shandong) Co., Ltd. China EUDAMED

Ref BK-BC32Model BK-BC series EMDN W02030201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69368953029BC***5M Basic UDI-DIDate20 Mar 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  • Withdrawn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 23 Oct 2026

Model / Reference
BK-BC series, BK-BC32
Primary DI / UDI-DI
06936895302902
Basic UDI-DI
69368953029BC***5M
EMDN Code
W02030201 Automated blood culture analysers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Biodustry(Shandong) Co., Ltd.

See all devices from Biobase Biodustry(Shandong) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • New Device
Other properties (9)
  • 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

Sources (1)

  • EUDAMED b3e1e6f3-800d-4d33-88d7-c6bfb8bd01bd 61 fields · synced 23 Oct 2026